Associate Director, PV Scientist

About This Role

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.

What You’ll Do

• 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).
• Respond to regulatory requests and support regulatory filing activities for topics and questions related to product safety.
• Lead and coordinate key departmental initiatives to advance the strategic goals of the Safety Surveillance and Aggregate Reports group.

Who You Are

You are deeply invested in ensuring the utmost safety for patients involved in clinical trials or using our approved treatments. With the ability to distill complex data into clear, actionable insights, you shine in a collaborative team setting. Your exceptional organization and time-management skills enable you to thrive in a fast-paced environment where your contributions make a significant impact on patient and public health.

Required Skills

• 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.

Pay

The base compensation range for this role is: $172,000.00-$237,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

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