Director, Pharmacovigilance & Drug Safety

Amneal

4d

About The Position

The Director, Clinical Safety and Pharmacovigilance heads the pharmacovigilance group and is responsible for pharmacovigilance and safety activities for Amneal products from clinical development through approval and postmarketing. The role oversees compliance with standard operating procedures and activities for detecting, assessing, and reporting adverse effects and other medicine-related safety concerns, ensuring that safety activities comply with national and international regulations.

The Director mentors team members on signal detection, safety responses, medical scientific literature, aggregate reports, medical assessments, and causality assessments. The role oversees safety profiles for investigational products and serves as the product safety expert, partnering with regulatory, labeling, marketing, clinical, and clinical operations teams to identify and address potential safety issues. The Director independently performs core signal detection activities and escalates program or portfolio issues affecting safety programs, priorities, resources, and milestones.

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 standard operating procedures, process improvements, and risk management initiatives.
• Mentor Safety Scientists, contribute to training, and support departmental planning.
• Perform other additional activities 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.
• Comprehensive, flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree