Validus Pharmaceuticals Jobs in Usa

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Job Description

Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.

Work Schedule: We offer both full-time and part-time shifts with flexible scheduling between 5:30 AM and 9:00 PM . Availability during these hours is required. Weekend shifts are scheduled on a rotating basis. We're looking for team members who can adapt to varying schedules to meet business needs.

About BioLife Plasma Services

Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

About the role:

Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS).

How you will contribute

• You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE).
• You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities.
• You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility.
• You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable.
• You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents.

• You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs.

What you bring to Takeda:

• High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements
• Currently licensed or certified in the state where responsibilities will be assigned: EMT-Paramedic

• Current Cardiopulmonary Resuscitation (CPR) and AED certification
• Fulfill state requirements (in state of licensure) for basic IV therapy
• Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
• Two years in a clinical or hospital setting

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.  

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.  

For Location:

U.S. Hourly Wage Range:

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type

Job Exempt

Job Title: Clinical Vendor Manager (Central Labs)

Location: Remote

Duration: 10 months

What are the top 3-5 skills, experience or education required for this position:

1. Demonstrates Central Lab SME expertise, as well as relationship & leadership competencies

2. Manager role - 3+ years of clinical development experience in pharmaceutical, healthcare, regulated industry, including 3+ years working with third-party vendors

3. Strong interpersonal, negotiation, communication, conflict resolution, and problem-solving skills

4. Manager role - demonstrates expertise in strategic alignment execution, supporting operational excellence in low to mid complex TAs with vendors; support partnership and study-level escalations

5. Bachelor's degree

As a member of the Vendor Strategy and Relationship (VSR), this role delivers operational value across the full vendor lifecycle. The role provides subject matter expertise (SME), fosters strategic alignment with vendors, and supports innovative, sustainable growth through operational excellence. The role ensures effective partnership management by centralizing expertise, standardizing processes, optimizing performance, and proactively managing risks and trends within the Therapeutic Areas (TA), organization and vendor(s).

This role leverages operational experience with partnership insights to align study and TA decisions with enterprise vendor strategies.

Responsibilities :

* Execute vendor selection strategies with business and study teams.

* Lead early engagement activities with study teams and vendor, advising on TA design risks, trends and key considerations.

* Lead internal vendor study kick-off meeting, co-lead joint vendor and study team kick-off meeting.

* Conduct 2nd round review on key vendor documents (e.g., contracts, study specifications) to ensure quality and alignment

* Provide financial health support to study teams

* Support partnership escalations and study-level escalations per escalation plan

* Analyze operational and metric trends to identify risks and implement TA solutions and mitigations that optimize performance and outcomes; raise TA trends for portfolio analysis - may support partnership solutions

* Educate study teams on database lock and close-out processes, provide guidance and risk mitigation support

* Develop TA standards, training resources, and deliver JIT training at key milestones to study teams; lead multi-study lessons learned and share across TA(s); may support partnership standards and training efforts

* Identify and/or support partnership enhancements and training; drive TA change management efforts

Qualifications :

* Bachelor's degree (or ex-US equivalent) is preferred, in a relevant field as business economics, science or health administration

* 3+ years of clinical development experience in pharmaceutical, healthcare, regulated industry (and/or applicable work experience); including 3+ years working with third-party vendors (and/or applicable work experience).

* Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).

* Demonstrates subject matter expertise within vendor category (e.g., capabilities, processes, technical) as well as relationship and leadership competencies

* Strong interpersonal, negotiation, communication, conflict resolution and problem-solving skills

* Expertise in analyzing intermediate business problems and data to design and implement innovative solutions

* Excellent cross-functional partnership skills; experience managing cross-functional initiatives to achieve objectives, timelines and change management

* Ability to influence internal/external stakeholders and drive decision-making in a collaborative working environment that allows for the appropriate levels of involvement and decision-making

Safety Monitor II

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.

• Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
• Reviews safety events.
• Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners.
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
• Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
• Coordinates with project staff.
• Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
• Ensures maintenance of documentation required by both corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
• Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.

• Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
• 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
• Experience in safety monitoring/pharmacovigilance preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

In this role, you will report to the Hiring Manager and will work closely with the Avantor's Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

Location:Springhouse, PA

Schedule:Monday - Friday 7 am - 3:30 pm

Hourly Rate:$20.30

Benefits:

• Health and Wellness: Medical, Dental, Vision, and Wellness programs (eligible for medical coverage on day 1)

• Time Off: Paid Time Off (PTO), company-paid holidays, Choice holidays, etc.

• Financial Well Being: Spending Accounts: Flexible Spending Account (FSA), Health Savings Accounts (HSA), commuter benefits, 401(k), tuition assistance, employee stock purchase plan discount

• Added Protection Coverage: To include critical illness, hospital indemnity, accident, legal, identity theft protection, pet, auto, and home insurance

• Recognition: Celebrate your peers and earn points to redeem for gifts and products.

What we're looking for

Education:High School Diploma or GED required

Experience:1-2 years of experience in a customer-facing or laboratory environment.

Collaboration Tool:Knowledge of Information, intermediate computer skills, including Microsoft Office, with proficiency in Word and Excel

Preferred Qualifications:

• Conform to all customer requirements for background checks, health and safety issues, security clearances, and medical checkups

• Requires knowledge in using various instruments to prepare for and perform tests

• Excellent Customer Service Skills; display a professional can-do attitude

• Perform duties with the highest regard for safety and quality

• Ability to understand and follow site protocols, policies, and procedures

• Must be flexible, forward-thinking, motivated, and have the ability to act independently

• Must be able to lift 25 lbs

How you will thrive and create an impact

Avantor's Advanced Laboratory Services team is a crucial part of the Avantor Services group serving over 500 customers in biopharma, pharmaceutical, educational, industrial, and high-tech industries with customizable, flexible solutions and end-to-end laboratory operations support.

• Complete routine laboratory procedures, such as but not limited to preparation of solvents, buffers, resins, reagent solutions, media prep, mixing of chemicals, etc.

• Report timely and accurate test results according to laboratory policies and procedures.

• Routine maintenance of lab equipment and troubleshooting.

• Store chemicals properly, dispose of chemical waste, adhere to safety procedures, and participate in safety programs.

• Manage inventory, maintain processes, and order laboratory supplies, including glassware and chemicals for biotech/pharmaceutical processes.

• Maintain records utilizing electronic laboratory notebooks (eLNs).

• Maintain files, track orders, and process shipping requests.

• Track and document chemical usage and inventory.

• Restocking glassware and chemicals.

• Maintain a clean room to prevent contamination and maintain the integrity of production.

• Calibrate balances and pH meters.

• Inspect laboratory safety stations.

• Perform other duties as assigned.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Job Description:

This position supports Patient Data Intake (PDI) organization to achieve its mission of improving patient lives through consistent and accurate delivery of high quality, relevant, and timely adverse event and product quality management by providing effective oversight of external providers of Pharmacovigilance services.

Major Responsibilities:

Core job requirements include:

* Conducting oversight of vendors who identify and collect adverse event information and complete intake of Pharmacovigilance safety reports in Safety System.

Conducting oversight of vendors who identify and collect product quality complaint information and complete intake of Product Quality reports in Product Quality System.

* Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event and product quality complaint information is performed in a compliant and timely manner to comply with global regulations.

* Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports and products complaints related to products.

* Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for supporting customers.

* Supporting vendor case quality and productivity metrics by exhibiting the core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One ; Decide Smart and Sure.

* Supporting and participating in audits and inspections as needed.

* Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal trainings as needed.

* Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.

* Conducting oversight in the vendors use of multiple databases to document adverse event and product complaint information.

* Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.

* Acting as an adverse event and product complaint intake subject matter expert.

* Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.

* Participating in projects/assignments in coordination with management.

* Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.

* Participating in projects/assignments in coordination with management.

* Other duties may be assigned based on the need or work requirements of the organization.

Experience/Skills:

Bachelor's degree with related health sciences background. Nursing or Pharmacy preferred

3-6 years clinical healthcare and previous pharmaceutical industry experience. Pharmaceutical industry contact center experience preferred

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.

Experience Level = 3-5 Years