Validus Pharmaceuticals Jobs in Usa

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

Open date: August 27, 2025

Next review date: Monday, Mar 23, 2026 at 11:59pm (Pacific Time)

Apply by this date to ensure full consideration by the committee.

Final date: Wednesday, Aug 26, 2026 at 11:59pm (Pacific Time)

Applications will continue to be accepted until this date, but those received after the review date will only be considered if the position has not yet been filled.

UC Berkeley Extension (UNEX), the continuing education branch of the University of California, Berkeley, has been building bridges between UC Berkeley and the public since 1891. UNEX serves the professional and continuing education goals of thousands of people each year and plays an essential part of the University mission to: extend the research and scholarship of UC Berkeley to a global community; increase access to higher education for non-traditional, online, and international students; and improve the workforce. UC Berkeley Extension is a part of the division under the leadership of the Dean of Extended Education that also includes Berkeley Summer Sessions, Berkeley Study Abroad, and Osher Lifelong Learning Institute.

UC Berkeley Extension invites applications for a pool of qualified, dynamic instructors with a commitment to undergraduate, professional, and continuing education in Clinical Research, Regulatory Affairs, and Biotechnology to teach one or more online courses each year for our Sciences, Mathematics, and Biotechnology department.

Courses are offered online:

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• Online instruction is delivered asynchronously through our learning management system (Canvas) or through synchronous live lectures (Zoom).
  
• Most synchronous live online lecture courses are offered in the evening and on the weekend (U.S.A. Pacific Time).
  

We are seeking qualified applicants who possess current subject matter expertise and/or teaching knowledge in (but not limited to) the following course subjects. For program and course descriptions, please refer to the departmental link below.

Clinical Research

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• Introduction to Clinical Research: Clinical Trial Phases and Design
  
• Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
  
• Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
  
• Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management
  

Regulatory Affairs

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• Principles of Regulatory Affairs: Pharmaceuticals and Medical Devices
  
• Submissions and Commercialization
  
• Preparation, Submission and Agency Interfacing
  
• Harmonization Across Worldwide Applications
  
• Post-Approval Activities
  
• Principles of Supply Chain and Manufacturing
  
• Principles of Product and Process Development
  
• Principles of Quality and Compliance
  
• Regulatory Compliance for Pharmaceutical Products
  

Other Biotechnology Courses

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• Drug Development Process
  
• Other Biotechnology course topics (please specify in your cover letter)
  

Teaching Experience

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• Classroom Teaching Experience
  
• Synchronous Online Teaching Experience (online lectures via Zoom)
  
• Asynchronous Online Teaching Experience (via learning management system)
  

The department seeks candidates who can support the success of all students through inclusive curriculum, classroom environment, and pedagogy. Specific duties and expectations will vary depending on the method of instruction including: Synchronous Live Online (Zoom) or Asynchronous Online (Fixed Date).

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• For synchronous instruction (live online courses), duties include but are not limited to: syllabus development; assignment development; lesson planning for class meetings; preparing and submitting required texts and course materials; reviewing and updating Canvas course site; and delivering lectures, presentations, and learning activities for all required hours of instruction.
  
• For asynchronous instruction (fixed date online courses), duties include but are not limited to: reviewing the syllabus and pre-populated online course content; learning and utilizing Canvas classroom management tools; and requesting any training needs from the Program Director or Department Director.
  
• For all instruction (regardless of course format) duties include but are not limited to: completing required trainings as mandated by the UC Presidential policies; responding to student questions and learning needs in a timely manner; grading student assignments and posting final student grades to the instructor portal in a timely manner; utilizing University-approved course support platforms including the Canvas Learning Management System, Zoom, Instructor Portal, Google Workspace, etc.; reviewing and following University and departmental policies, logistics, and other guidelines as published on the departmental Instructional Resource Site; and responding to other requests from the Program Director or Department Director in a timely manner.
  

Clinical Research Conduct and Management Program: public/category/ ?method=load&certificateId=17168&selectedProgramAreaId=15498&selectedProgramStreamId=15604

Regulatory Affairs Program: public/category/ ?method=load&certificateId=17180

Clinical Research, Regulatory Affairs, and Biotechnology Courses: academic-areas/sciences-and-biotechnology/?nav=5#!?tab=courses&programStream=Life%20Science%20Business%20and%20Biotechnology

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• Advanced degree
  

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• 
  U.S.A. Residency and U.S.A. Work Authorization: All work must be performed in the United States, whether in person or online. For applicants who are not US citizens or permanent residents, a valid US work authorization is required for the duration of employment. Applicants should not expect the department to sponsor a work visa on their behalf.
  

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• Doctorate degree or equivalent international degree in course subject.
  
• 3 or more years of teaching, training, or coaching experience in the course subject at a U.S. college/university institution, or within a U.S. Clinical Research, Regulatory Affairs, or other Biotechnology corporate environment.
  
• Knowledge of federal and California state laws and regulations as applicable to the course subject.
  
• Professional license, certification, or credential within a Clinical Research, Regulatory Affairs, or other Biotechnology field.
  
• Experience in creating syllabi, learning objectives, lectures/presentations, learning activities, assignments, assessments, exams, and quizzes.
  
• Experience teaching and/or developing academic content for online courses.
  
• Ability to convey conceptual and complex ideas and information.
  
• Ability to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.
  
• Effective verbal/written communication and presentation skills (English).
  
• Effective organizational skills with attention to detail.
  
• Ability to collaborate with colleagues and work within a team environment.
  
• Proficiency in (or willingness to learn) instructional and other technology, such as: Learning Management Systems (Canvas); lecture/presentation capture applications (Panopto); online video conferencing (Zoom); Microsoft Office (Word and PowerPoint); file sharing (Google drive or Dropbox); and Google Workspace tools (email, calendar, docs, sheets, slides, etc).
  

• Curriculum Vitae - Your most recently updated C.V.

  
  

• Cover Letter - Please discuss prior teaching experience, teaching approach, and other/future teaching interests. This can include, for example, specific efforts, accomplishments, and future plans to support the success of all students through inclusive curriculum, classroom environment, and pedagogy.

  
  

• 
  
• References are requested from candidates at the interviewing stage, and references are only contacted for finalists.
  

Help contact:

UC Berkeley is committed to diversity, equity, inclusion, and belonging in our public mission of research, teaching, and service, consistent with UC Regents Policy 4400 and University of California Academic Personnel policy (APM 210 1-d). These values are embedded in our Principles of Community, which reflect our passion for critical inquiry, debate, discovery and innovation, and our deep commitment to contributing to a better world. Every member of the UC Berkeley community has a role in sustaining a safe, caring and humane environment in which these values can thrive.

The University of California, Berkeley is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.

For more information, please refer to the University of California's Affirmative Action and Nondiscrimination in Employment Policy and the University of California's Anti-Discrimination Policy.

In searches when letters of reference are required all letters will be treated as confidential per University of California policy and California state law. Please refer potential referees, including when letters are provided via a third party (i.e., dossier service or career center), to the UC Berkeley statement of confidentiality prior to submitting their letter.

As a University employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.

Unless stated otherwise, unambiguously, in the position description, this position does not include sponsorship of a new consular H-1B visa petition that would require payment of the $100,000 supplemental fee.

As a condition of employment, the finalist will be required to disclose if they are subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct.

• 
  
• "Misconduct" means any violation of the policies or laws governing conduct at the applicant's previous place of employment, including, but not limited to, violations of policies or laws prohibiting sexual harassment, sexual assault, or other forms of harassment or discrimination, as defined by the employer.
  
• UC Sexual Violence and Sexual Harassment Policy
  
• UC Anti-Discrimination Policy
  
• APM - 035: Affirmative Action and Nondiscrimination in Employment
  

Dir II HSE Program

Chicago, IL (Hybrid)

The American Medical Association (AMA) is the nation's largest professional Association of physicians and a non-profit organization. We are a unifying voice and powerful ally for America's physicians, the patients they care for, and the promise of a healthier nation. To be part of the AMA is to be part of our Mission to promote the art and science of medicine and the betterment of public health.

At AMA, our mission to improve the health of the nation starts with our people. We foster an inclusive, people-first culture where every employee is empowered to perform at their best. Together, we advance meaningful change in health care and the communities we serve.

We encourage and support professional development for our employees, and we are dedicated to social responsibility. We invite you to learn more about us and we look forward to getting to know you.

We have an opportunity at our corporate offices in Chicago for a Dir II HSE Program (USAN) on our Health, Science, and Ethics team. This is a hybrid position reporting into our Chicago, IL office, requiring 3 days a week in the office.

As a Dir II HSE Program, you will direct the operations of the United States Adopted Names (USAN) Program and serve as Secretary to the USAN Council. Serve as an International Nonproprietary Names (INN) expert for the World Health Organization's INN Program.

RESPONSIBILITIES:

USAN Program Operations

• Oversee day-to-day operations of the USAN Team including managing USAN and INN applications and the negotiation, approval, and payment process for all generic drug names in the United States.
• Provide operational and governance guidance and oversight to USAN Program staff by ensuring adherence to USAN policies.
• Serve as a liaison with the FDA and WHO.
• Responsible for managing USAN's operating budget, ensuring timely revenue recognition to meet financial targets.
• Responsible for establishing USAN-specific goals and providing input to help shape and implement BU-level processes.

Nonproprietary Naming Lifecycle

• Conduct negotiations for nonproprietary names for drugs, both small molecules and biologics, pharmaceutical aids, and veterinary drugs marketed in the United States between drug manufacturers, the USAN Council, and the World Health Organization (WHO)
• Serve as single point of contact with pharmaceutical clients throughout the drug naming lifecycle.
• Conduct extensive research on the availability and appropriateness of the suggested names and stems.
• Prepare and review analysis of related agents for applications.
• Ensure established nomenclature and chemical format standards are followed.
• Read and report on drug nomenclature and medical literature to maintain skills for this position including monitoring and interpreting advances in the field of nomenclature.

Secretary to the USAN Council and INN Program Expert

• Conduct biannual USAN Council meetings. Responsible for the agenda, organization and content of USAN Council meetings. Present USAN requests and new policies for review by the USAN Council at these meetings.
• Act as primary contact and spokesperson for the USAN Council; provide nomenclature guidance to manufacturers by directly communicating and explaining USAN rules and processes.
• Conduct reviews of all INN applications and make recommendations to the INN Secretariat.
• Attend INN Expert Consultation meetings twice per year to approve USAN and INN requests submitted to the INN Program.

Staff Management

• Lead, mentor, and provide management oversight for staff.
• Responsible for setting objectives, evaluating employee performance, and fostering a collaborative team environment.
• Responsible for developing staff knowledge and skills to support career development.

May include other responsibilities as assigned

REQUIREMENTS:

1. Master's Degree required.
2. Ph.D. or PharmD desirable.
3. 10+ years of experience in a health-related setting that includes deep expertise in drug classification and activity is required.
4. 5+ years' experience in people management required; able to attract and develop talent.
5. Substantive knowledge, training, and background in biochemistry, pharmacy, pharmacology and / or the biological sciences is required.
6. Proven track record of managing Profit & Loss (P&L) accountability preferred.
7. Familiarity with specialized software applications (such as Clarivate, ChemDraw) and chemical databases (such as Chemical Abstract Service).
8. Well-developed negotiation, arbitration, and meeting facilitation skills.
9. Excellent prioritization and organization skills.
10. Polished relationship building and management skills needed for external and internal relationships.
11. Excellent verbal communication, writing skills, and presentation skills with proven experience.
12. Both domestic and international travel required.

The American Medical Association is located at 330 N. Wabash Avenue, Chicago, IL 60611 and is convenient to all public transportation in Chicago.

This role is an exempt position, and the salary range for this position is $152,939-$206,519. This is the lowest to highest salary we believe we would pay for this role at the time of this posting. An employee's pay within the salary range will be determined by a variety of factors including but not limited to business consideration and geographical location, as well as candidate qualifications, such as skills, education, and experience. Employees are also eligible to participate in an incentive plan. To learn more about the American Medical Association's benefits offerings, please click here.

We are an equal opportunity employer, committed to diversity in our workforce. All qualified applicants will receive consideration for employment. As an EOE/AA employer, the American Medical Association will not discriminate in its employment practices due to an applicant's race, color, religion, sex, age, national origin, sexual orientation, gender identity and veteran or disability status.

THE AMA IS COMMITTED TO IMPROVING THE HEALTH OF THE NATION