Job Details
Posted 24 August, 2026
Job Id: 630207
Medical Affairs/Safety – Manager, PV Scientist
Job Description
Summary of Key Responsibilities
*Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
*Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
*Assists in evaluation and development of Safety Management Plans
*Assists in data analysis compilation and presentation at cross-functional meetings.
*Assists in the evaluation of potential safety issues.
*Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
*Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
*Assists in RMP and DRMP development and updates.
Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
Qualifications
Education: Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience: A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong skills and experience in:
Ability to work in a matrix environment in accordance with the company leadership commitments and values.
Excellent planning, organization, written and oral communication skills
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Understanding Signaling tools (eg. Empirica)
Experience in clinical patient care is a plus
Regulatory Inspection readiness experience is a plus
Supervision: Individual is expected to work independently with support from management and colleagues in SRM.
Pay ranges between 100-115/hr based on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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