Associate Pharmacovigilance Scientist
Associate Pharmacovigilance Scientist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 Youll 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 safetyrelated 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 crossreferencing
- Support with Quality Checks for documents authored within the SSA team
Qualifications :
Required Skills
- Bachelors Degree in biologic or natural science; or health care discipline.
- Minimum 3 years industry experience with a minimum of 3 years of PV experience.
Preferred Skills
- Advanced degree (PhD MPH NP PharmD etc.) preferred.
- Safety case processing experience or relevant exposure to PV Scientist tasks.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
