Director, Pharmacovigilance & Drug Safety
About The Position
The Director, Clinical Safety and Pharmacovigilance heads the pharmacovigilance group and oversees pharmacovigilance and safety activities for Amneal products from clinical development through approval and post-marketing. The role is responsible for compliance with standard operating procedures and for activities involving the detection, assessment, and reporting of adverse effects and other medicine-related safety concerns, in accordance with national and international regulations. The Director mentors team members in signal detection, safety responses, medical scientific literature, aggregate reports, medical assessment, and causality assessment. This person oversees safety profiles for investigational products, serves as a product safety expert, and partners with regulatory, labelling, marketing, clinical, and management teams to raise potential safety issues and support clinical operations. The role independently performs core signal detection and escalates program or portfolio issues affecting safety programs, priorities, resources, and milestones. The position also provides medical safety leadership for clinical trials and development programs; reviews safety data, documents, and regulatory submissions; oversees outsourced clinical safety activities; supports compliance and inspection readiness; and serves as the sponsor’s medical safety lead in applicable DSMB and IDMC interactions. The Director provides backup coverage for other Medical Directors, supports process improvement and risk management, mentors Safety Scientists, and contributes to training and departmental planning.
Requirements
- Doctorate degree: MD required.
- 10 or more years of Clinical Safety experience.
- In-depth knowledge of clinical trial safety across the product lifecycle, including SAE assessment, causality and expectedness, reference safety information, expedited safety reporting, aggregate clinical data review, signal evaluation, benefit-risk assessment, and risk mitigation.
- Demonstrated hands-on experience with protocols, Investigator’s Brochures, Safety Management Plans, DSURs, clinical study reports, safety committees, and regulatory responses.
Responsibilities
- Assess significant safety cases, review cumulative safety data, evaluate signals and benefit-risk, and recommend safety actions.
- Lead medical safety oversight for assigned clinical trials and development programs, including study teams and safety governance.
- Provide medical safety input and review for study documents, safety reports, and regulatory submissions.
- Review and approve, within delegated authority, clinical safety narratives, aggregate analyses, and medical assessments supporting safety reports and regulatory submissions.
- Provide medical input into Development Safety Update Reports (DSURs), investigator brochure updates, clinical overviews, integrated safety summaries, and responses to health authority questions.
- Oversee outsourced clinical safety activities and support compliance, inspection readiness, and cross-functional coordination.
- Serve as the sponsor’s medical safety lead for interactions with Data Safety Monitoring Boards (DSMBs) and Independent Data Monitoring Committees (IDMCs), as applicable.
- Provide backup coverage for other Medical Directors across designated clinical and marketed products, within training and delegated authority.
- Support SOPs, process improvements, and risk management initiatives.
- Mentor Safety Scientists, contribute to training, and support departmental planning.
- Oversee pharmacovigilance and safety activities for Amneal products from clinical development through approval and post-marketing.
- Ensure pharmacovigilance and safety activities comply with standard operating procedures and national and international regulations.
- Mentor team members on signal detection, safety responses, medical scientific literature, aggregate reports, medical assessment, and causality assessment.
- Partner with regulatory, labelling, marketing, clinical, and management teams to raise potential safety issues and support clinical operations.
- Independently perform core signal detection and escalate program or portfolio issues affecting safety programs, priorities, resources, and milestones.
- Perform any other additional activity as needed.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award.
- Long-term incentive award, such as restricted stock units, within the first 12 months.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
