Senior Director PV Risk Management, Benefit/Risk
Greater Boston area
A pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines are currently seeking a Senior Director PV Risk Management, Benefit/Risk as their company is rapidly expanding! This 10 ten global pharma company has received recognition for their overall success and is looking to increase headcount within the Pharmacovigilance department. Now is a pivotal time to get in with this group as the Senior Director PV Risk Management, Benefit/Risk will have the ability to lead and impact their robust pipeline of promising new medicines.
The Senior Director PV Risk Management, Benefit/Risk will have the following responsibilities:
- Provides global strategic leadership and subject matter expertise in risk management / risk evaluation and mitigation strategies, in the assessment of product benefit-risk across therapeutic areas within company's Global Patient Safety and Evaluation (GPSE)
- Advise on the strategy, preparation and authoring of RMPs for products across therapeutic areas
- Advise teams on adequate responses to health authority queries relating to product RMP, REMS and benefit-risk assessment
- As applicable, lead the development of additional risk minimization tools with scientifically balanced content grounded in risk minimization principles
- Oversee implementation of risk minimization activities by local operating companies and ensure local risk management activities are aligned with the core risk management strategy
- Oversee and maintain collaborative working environment with vendors, on RMP/REMS activities
- Ensures product team compliance with GPSE risk management and benefit-risk processes, as well as current RMP/REMS regulatory trends/guidelines and best practices
The ideal candidate will have the following skill set:
- Advanced degree in life sciences or MD required
- Minimum 10 years of pharmaceutical/device industry experience with at least 5 years in pharmacovigilance and risk management
- Prior leadership and management experience (preferred)
- Experience in liaising with regulatory agencies, professional groups and/or academic centers
- Experience with developing risk management plan or risk evaluation and mitigation strategy, risk minimization tools, authoring RMP and REMS
- Experience with the application of a benefit-risk assessment framework
- Experience with assessing the effectiveness of additional risk minimization measures or activities, and the evaluation of REMS methods
