The Executive or Director, Pharmacovigilance and Drug Safety
Will require in-depth subject matter expertise, strong operational strategic thinking and leadership skills to effectively manage safety and global pharmacovigilance, including both developing a departmental strategy as well as managing the-day to day operations. The role oversees and pharmacovigilance for marketed drugs, responsible for individual and aggregate case reporting and partnering with the CSO, for global safety risk management.
This position is virtual and reports to Raleigh, NC office.
- Background or degree in healthcare sciences is highly desirable (PharmD, nursing, PA, etc.).
- Candidates who have extensive experience with both pharmacovigilance operations and safety evaluation may be considered.
- Strong knowledge and track record in pharmacovigilance operations including case management, individual and aggregate case reporting (US and EU). Experience with pharmacovigilance of marketed drugs. Experience with safety data review, signal detection (including individual and aggregate data analysis), risk management, labeling, and benefit-risk assessment in the context of aggregate reports (PBRER) is desirable.
- Experience with documentation and communication of safety assessments is desirable.
- A minimum of 5 years of pharmacovigilance experience.
- Experience and knowledge of safety databases
- Strong knowledge of medical terminology.
- Advanced knowledge of FDA, EU regulations, and ICH guidelines relating to pharmacovigilance.
- Ability to build cross-functional relationships.
- Travel of up to 15% may be required.
- Oversight of the global Pharmacovigilance (PV) operations to ensure compliance with applicable regulatory PV requirements and guidance.
- Management of external pharmacovigilance vendor(s) including quality oversight of case reporting, signal detection/aggregate analysis, multiple safety data exchange agreements, and contract/budget management.
- Ensure that the Pharmacovigilance function (in house and outsourced), is operationalized according to the highest industry standards, as well as compliance with the company’s Policies and SOPs.
- Oversee pharmacovigilance compliance and quality management function within PV to ensure compliance with local and international safety requirements and regulatory inspection readiness.
- Oversee and contribute to the production of aggregate safety reports including PADERs, PBRERs.
- Provide relevant information and feedback to stakeholders for other aggregate reports (e.g., DSURs, IND annual reports, investigator brochures).
- Oversee vendor and partner audits as appropriate, ensure inspection readiness and serve as lead contact for regulatory audits.
- Oversee and update SOPs.
- Apply knowledge of US and EU pharmacovigilance regulations and ICH pharmacovigilance guidelines to day-to-day operations of pharmacovigilance
- Ensure that labeling and risk management plans are accurate and up to date.
Location: Home office, Virtual
Compensation: Salary DOE. Bonus up to 25%. Full Benes. Stock Options