Supports Signal Management activities in collaboration with, and oversight from, the PV Scientists:
Evaluate safety data and conduct signal management activities. This may include updates to signal detection plans, contribution to or authoring of meeting reports, presentations and minutes, and may also include authoring sections of signal evaluation reports.
Support updates to RMPs
Collaborate with Global Safety Officers (Safety physicians)
Represent SSA in cross functional meetings with other departments, such as Regulatory and Clinical Development
Perform ICF review, AE coding review and other clinical trial safety-related activities
Conduct literature review
General administrative tasks (request subject matter experts for information, scheduling of activities, providing information for trackers, requesting database outputs)
Supports Aggregate Report preparation in collaboration with the PV Scientists:
Supports with the preparation of aggregate safety reports such as PSURs, DSURs
Perform data review and verification:
Technical and scientific reviews including source data verification
Editorial review; ensure grammatical and stylistic consistency and accuracy
Formatting, internal linking, and external cross-referencing
Support with Quality Checks for documents authored within the SSA team
Requirements
Required Skills
Bachelor's Degree in biologic or natural science; or health care discipline.
Minimum 3 years industry experience with a minimum of 3 years of PV experience. Safety case processing experience or relevant exposure to PV Scientist tasks preferable.
Preferred Skills
Advanced degree (PhD, MPH, NP, PharmD, etc.)
Job Level: Professional
Additional Information
The base compensation range for this role is: $106,000.00-$138,000.00
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?
All qua
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave
Additional Information
About This Role
The Associate PV Scientist serves as a critical team member within the Safety Surveillance and Aggregate Report (SSA) team for products or product groups, including supporting with signal management activities, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, and conducting safety literature reviews. The role will cover activities relating to marketed and/or investigational products.
Biogen · Cambridge, MA