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).
• 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.
• 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.

This position is Hybrid based out of our Cambridge, MA office 

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 European Marketing Authorization application filing, 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.

Additional Information