Associate Director, PV Scientist
About The Position
As the Associate Director for the Safety Surveillance and Aggregate Reports group, you will play a critical part in ensuring the safety and efficacy of our products while fostering a collaborative and high-performing team environment. You will serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight. You will oversee signal detection and management activities, Risk Management Plans (RMPs – core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs). You will demonstrate leadership and interact collaboratively and effectively in a team environment including Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues. You will respond to regulatory requests and support regulatory filing activities for topics and questions related to product safety. For roles with line management, you will be required to manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists. You may be accountable for departmental processes, ensuring strict compliance with global PV regulations as well as process improvements. You may lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group.
Requirements
- Minimum 10 years Pharmacovigilance experience, including experience in safety signal management, responses to health authorities, aggregate safety reports writing in both clinical trial setting and post-marketing.
- Experience in authoring and leading safety sections for Global Filings (e.g., US NDA, EU MAA), including authoring and leading the EU Risk Management Plan
- Experience in authoring signal evaluation or analysis, authoring (safety) Risk Management Plans (RMPs – core and EU) and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
- Understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Ability to assess resource needs and adapt accordingly.
- Represent and speak to processes in cross-Safety and cross-functional forums.
Nice To Haves
- The preference for this position is Hybrid based out of our Cambridge, MA office.
Responsibilities
- Serve as the lead PV Scientist for a specific product or group of products (investigational and/or marketed), providing strategic direction and scientific oversight.
- Oversee signal detection and management activities, Risk Management Plans (RMPs – core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
- Demonstrate leadership and interact collaboratively and effectively in a team environment including Safety MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory colleagues.
- Respond to regulatory requests and support regulatory filing activities for topics and questions related to product safety.
- Manage, mentor, and train a team that may include associate PV Scientists, PV Scientists, and Senior PV Scientists (for roles with line management).
- Be accountable for departmental processes, ensuring strict compliance with global PV regulations as well as process improvements (may be required).
- Lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group (may be required).
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
