This Medical Director, Pharmacovigilance position will directly report to the Senior Medical Director, Head of Pharmacovigilance. This position is responsible for the accurate and timely reporting of product safety information to the organization and regulatory authorities world-wide as assigned by the Head of Pharmacovigilance.

• Provide medical support to the PV team for ICSR (Individual Case Safety Report) review of all products (branded and generics) within the American Regent Portfolio as assigned.

• Support the life cycle management and benefit-risk framework of the products, overseeing the proper and timely collection and reporting of adverse event information from all sources as required by regulation (clinical trials, literature, direct report, etc.).
• Preparation of all safety reports (IND Safety Reports, IND / NDA updates, PADERs, PSURs, Annual reports, Adhoc requests etc.) and assist in the medical review of clinical study reports (CSRs) and Investigator Brochure (IB)
• Development, maintenance, and compliance with Pharmacovigilance-related SOPs.
• Provide medical support to the team in the evaluation of adverse event trending reports and any ad hoc safety requests as assigned.
• Provide medical support to the team in the analysis of reports pertaining to signal detection/surveillance activities at a medical qualitative level.
• Provides medical support, as assigned by the supervisor, for Data Safety Review Board reviews/label evaluations/ clinical protocol development
• Provides medical review/commentary and Risk Assessments related to adverse drug event reports or associated with quality investigations on an individual case-level or aggregate review level.
• Liaises with company Legal Department regarding medical review/commentary for cases of special interest and matters of regulatory interpretation.
• Assist the assigned Medical Director within Clinical Research and Development as needed and participate within a Clinical Study Project Team.
• Interaction with FDA and other regulatory authorities for inspections, audits, teleconferences, and other interactions as necessary.
• Develop and implement Pharmacovigilance programs and risk management plans.

Administration

• Administrative tasks as required by the Direct Supervisor to maintain smooth functioning of the business unit and compliance with Regulation, Guidance and SOPs.
• Participate in training lectures, symposia and conferences in order to maintain current license and maintain and promote Company's therapeutic area(s) expertise.
• Perform any other tasks/duties as assigned by management.

Required Knowledge, Skills and Abilities:

• A medical degree with at least 3-5 years of direct medical care experience. Active licensure within a field of medicine is required. U.S. Licensure preferred.
• At least 3 years of pharmaceutical industry experience (in pharmacovigilance and drug safety surveillance, knowledge of drug development safety requirements and history of experience working with safety monitors essential.
• Working knowledge of FDA reporting regulations as they pertain to human and medical devices for both marketed products and products under clinical development.
• Excellent oral and written English communication skills.
• Significant computer / technology skills. ARGUS safety database experience preferred.
• Ability to prioritize and perform multiple tasks simultaneously.
• Ability to make decisions independently and with appropriate input.
• Ability to work well in a matrix environment, particularly with Clinical Research and Development, Project Management, Regulatory Affairs, Legal, Quality Assurance, Sales, Marketing.
• Flexibility in adapting to multiple therapeutic areas interchangeably to support the business needs.
• Be engaged with cross-functional teams and provide safety representation as directed by the supervisor.
• Be a team player, exemplify respectful values, and be collaborative both within the PV team, Clinical team, Regulatory Affairs, Legal, and externally with cross-functional groups.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.