Associate Director, Pharmacovigilance Scientist

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.
• 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

Requirements

• Required Skills
• Requires a minimum of a Bachelor's degree in a biological or natural science, or health care discipline (e.g. nursing, pharmacy).
• 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.
• Job Level: Management
• Additional Information
• 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.
• Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
• In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
• 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
• Why Biogen?

Benefits

Additional Information

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.

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