Executive Director/Global Head, Drug Safety/PV (MD, PhD or PharmD): Very stable, growing Biopharma – Central NJ: RETAINED SEARCH
SUMMARY: Cornerstone has been retained by a very stable and growing Biopharma. They are looking to hire a newly created position for an Executive Director/Global Head of Drug Safety & Pharmacovigilance. You will have complete ownership of the Drug Safety/PV function to include strategy, operations, risk management, signal detections, and growing a team. Our client offers a “best of both worlds” working environment. They operate in a nimble and creative work environment with an exceptional culture which is exemplified by the incredible tenure of their employees. While operating like a smaller company without the typical larger company obstacles, they are also extremely stable to include a marketed product (cardiovascular/metabolic focus) and a strong appetite for further growth.
POSITION: Executive Director, Global Drug Safety & Pharmacovigilance
LOCATION: Our client is located in an ideal part of Central NJ that allows for candidates to commute from Northern, Southern and Central NJ as well as Eastern PA.
ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:
- Company Culture/Environment: People genuinely like to work here, and they stay. The tenure of their employees is well above industry average. They offer a culture and environment that is highly collaborative, trusting and forward-thinking.
- Visibility: A challenging, highly-visible role where you will work alongside of C-level Executives. You will work very closely with and report directly to the CSO who is hands-on and highly respected within Industry.
- Marketed Product: Our client already has a marketed product with an appetite for further growth and development. This is not a typical high-risk Biotech focused solely in Clinical Development without revenue coming in.
- Growth Potential: This company is looking to continue to grow both as a whole and within the Drug Safety & Pharmacovigilance.
- Serve in a critical role safeguarding the health of patients who are administered ’s product(s) through the oversight of the collecting, evaluating, reporting and collating of adverse events.
- Ensure compliance with internal as well as external global regulatory and safety requirements.
- Implement a scientifically valid early alert system to proactively discover trends and issues to provide company management with a global view of product safety.
- Lead the design, implementation and management of applicable Risk Evaluation and Mitigation Strategies (REMS).
- Define the strategic Pharmacovigilance and REMS plans and policies consistent with company and Global Regulatory Authorities and ensure a compliant global PV system including a PV Auditing Department and PV Compliance Department.
- Evaluate and implement outsourcing or in-house staff strategy, in collaboration with Medical Affairs, R&D, Regulatory, and other functions, on a continuous basis to optimize Pharmacovigilance capabilities for effectiveness, efficiency, and patient focus.
- Oversee the medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports.
- Medical evaluation of all other relevant safety information across clinical trials, scientific literature, and non-clinical studies for on-going surveillance and signal detection.
- Ensure compliance worldwide with applicable regulatory requirements related to Pharmacovigilance and REMS.
- Provide medical expertise on the safety profile and appropriate risk minimization measures to risk management plans.
- Identify and evaluate safety signals.
- Prepare responses to regulatory agency inquiries regarding product safety, benefit-risk relations and risk management.
- Organize and lead safety related audit inspections globally.
- Chair the Safety Committee [a multi-functional group (Medical, Marketing, R&D, Regulatory Affairs, Manufacturing, Legal, etc.)], to discuss signals from safety data collected from various channels.
- 10+ years of Drug Safety/Pharmacovigilance experience to include extensive pharmaceutical experience with demonstrated/increasing responsibilities.
- Strong leadership experience to include managing a team as well as cross-functional relationships.
Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not be shared with any parties outside of Cornerstone Search Group without your prior permission.
Thomas Fascia | Partner
P: 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
PO Box 5657 | Parsippany, New Jersey 07054 USA