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
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?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
