About This Role:As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical PV activities. Your responsibilities encompass managing the safety signal process, authoring aggregate reports like PSURs and DSURs, and addressing safety inquiries from both internal and external stakeholders. You'll delve into medical and scientific literature to extract vital safety information while supporting Clinical Trial PV medical activities. Collaborating with the Associate Director, you will also hire, train, and mentor staff dedicated to product-specific tasks. Your role as a Subject Matter Expert ensures compliance with global safety regulations and guidelines, fostering data analysis and product information sharing across cross-functional teams. This position is vital for maintaining the integrity and continuity of clinical trials and marketed products, ensuring they meet regulatory standards globally.
What You'll Do:- Lead the signal management process, including signal detection, documentation, and safety risk decisions for assigned products.
- Author signal evaluation reports and manage literature review for safety information.
- Respond to safety questions from regulatory authorities and lead Aggregate Report management.
- Finalize aggregate safety reports such as PSURs, DSURs, REMS, and RMPs for assigned products.
- Collaborate with Global Safety Officers and Safety MDs on investigational programs, including clinical trial activities and safety committee management.
- Manage data analysis, signal detection, and product activities as assigned.
Who You Are:You are a passionate, resourceful, and motivated PV Scientist with strong problem-solving capabilities who brings enthusiasm to the role. You excel in understanding and interpreting complex scientific data, presenting it clearly both verbally and in writing. Your ability to collaborate effectively in a team environment and apply clinical judgment makes you an ideal fit for this position. You thrive in a dynamic setting where prioritization and organizational skills are key.
Required Skills:- Bachelor's Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
- Significant and proven Pharmacovigilance experience, including aggregate safety reports and safety signal management.
- Ability to interpret, analyze, and present scientific and medical data clearly.
- Experience leading and conducting projects related to signaling and regulatory agency requests.
- Strong foundation in Pharmacovigilance and drug development, including knowledge of safety regulations.
- Proficiency in common data processing software (Excel, PowerPoint, Microsoft Word).
- Leadership skills and collaborative interaction in team environments, internally and externally.
- Strong organizational skills with the ability to prioritize independently.
Preferred Skills:- Knowledge of common safety database systems.
- Experience in interacting with cross-functional teams such as Clinical Development and Regulatory.
Job Level: Management
Additional InformationThe base compensation range for this role is: -
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
Job Level: Management
