Description:

The Director, Clinical Safety and Pharmacovigilance, heads the pharmacovigilance group and is responsible for all Pharmacovigilance and Safety related activities for all Amneal products from clinical development to approval and post marketing activities. The person is responsible for oversight of compliance with standard operating procedures and activities relating to the detection, assessment, and reporting of adverse effects or any other medicine-related safety concerns. This position ensures all safety and pharmacovigilance aspects are managed in accordance with national and international regulations. The Director, Clinical Safety and Pharmacovigilance mentors' other team members on all aspects of core signal detection, safety responses, Medical Scientific Literature, Aggregate Report, Medical Assessment and Causality Assessment. The person oversees all aspect's related to safety profiles for investigational products, serving as the product safety expert, working in partnership with team members from regulatory, labelling, marketing to bring potential safety issues to the attention of the clinical team and upper management, and supporting clinical operations teams with respect to safety-related issues as required. Independently performs core signal detection activities and elevate program or portfolio issues impacting key Safety programs, priorities, resources, and milestones.

Essential Functions:

• 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.
• Any other additional activity as needed
• 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.

Additional Responsibilities:

• 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.

Qualifications

Education:

• Doctorate Degree MD - Required

Experience:

• 10 years or more in Clinical Safety experience

Specialized Knowledge:

• 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.

The salary range for this position ranges from $200,000 - $250,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
 

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.