Pharmacovigilance Scientist

Biogen•Cambridge, MA

1d•Hybrid

About The Position

PV Scientists are responsible for assigned tasks for designated products or product groups. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve either as a lead PV Scientist or supporting PV Scientist, depending on his/her assigned product or product groups. Irrespective, the PV Scientist is a critical team member whose responsibilities include performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. The PV Scientist, with oversight from their manager, will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data output and analyses, and product information. This position is Hybrid based out of our Cambridge, MA office

Requirements

Bachelor’s Degree in biologic or natural science; or health case discipline.
Minimum 5 years industry experience, with a minimum of 3 years of PV experience

Nice To Haves

Advanced Degree preferred (PhD, MPH, NP, PharmD, etc.)

Responsibilities

Collaborates on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs.
Facilitates signal management process for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Global Safety Officer, Safety physicians and Sr. PV Scientist / AD, performs routine signaling activities including evaluation of safety data for new signals as part of ongoing pharmacovigilance activities. May include authoring signal evaluation reports, or sections of signal evaluation reports.
Conducts literature review for safety information and interacts with other groups to obtain necessary data (i.e., Epidemiology, SAE data).
With Sr. PV Scientist / AD oversight, collaborates with Clinical Trial physicians and Global Safety Officers on assigned investigational programs including protocol review, safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.
In collaboration with Sr. PV Scientist / AD, coordinates and authors responses to safety questions from regulatory authorities for assigned products.
Contributes to initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical, Clinical Operations, and Regulatory), as well as with external colleagues
Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
Oversees and mentors less experienced PV Scientist staff.
Applies clinical judgment to interpret case information.
Familiarity with Pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.

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