Associate Pharmacovigilance Scientist
About The Position
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. What You’ll Do 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 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.
Requirements
- 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.
Nice To Haves
- Advanced degree (PhD, MPH, NP, PharmD, etc.)
Responsibilities
- Evaluate safety data and conduct signal management activities.
- 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 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
