Director, Pharmacovigilence and Safety Science
Enigma Search, South San Francisco, CA, United States
Director, Pharmacovigilence and Safety Science
About the job Director, Pharmacovigilence and Safety Science
About the Company
Our client is looking for a Director, Pharmacovigilence and Safety Science. In this role, you will lead the safety science and pharmacovigilance (PV) function, providing critical expertise and support for our clinical programs which span common and rare diseases in nephrology and cardiometabolic indications. You will lead safety surveillance, adverse event reporting, and risk management activities, as well as supporting the development of critical PV and safety governance processes. In addition, you will collaborate closely with cross-functional partners to shape strategic plans for both early and late stages of clinical development. This position reports to the Head of Clinical Development.
Duties
- Lead safety surveillance and signal identification activities and the development of appropriate risk mitigation strategies
- Lead the Safety Management team and provide oversight for the development and execution of safety management plans in collaboration with other cross-functional study team members
- Provide oversight for case processing and AE reporting in accordance with regulatory requirements
- Provide oversight for the preparation and review of aggregate safety reports
- Lead the authoring and maintenance of safety-related information in clinical study documents and regulatory submissions
- Provide oversight for drug safety and pharmacovigilance services outsourced to CROs, consultants, and other vendors
- Participate in the presentation of data and discussions with KOLs, other external advisors, and health authorities
Qualifications
- Advanced degree in health sciences (MD/DO, PharmD, PhD) with a minimum of 4+ years of experience in pharmacovigilance and drug safety.
- Experience in late-stage clinical development is preferred
Required Skills
- Knowledge and experience in regulations pertaining to pharmacovigilance
- Knowledge and experience in medical review of individual case reports, signal detection and analyses of trends, and development of risk mitigation plans
- Knowledge and experience in the preparation and review of aggregate safety reports, safety-related sections of clinical study documents, and responses to regulatory queries
- Experience with management of external CRO/vendor partners
- Positive and enthusiastic disposition, adaptability to changing environments, and high personal and ethical standards in approaching corporate goals
- Ability to travel domestically (up to 20%) for internal meetings and other ad hoc meetings