“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
- Experience in Signal Detection and data analysis
- Review or aggregate data
- Writing of periodic reports
Day to Day Responsibilities:
Key Activities Applicable tasks may vary by product(s) assigned.
- The PV Scientist Manager is responsible for the following:
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- In collaboration with the Global Safety Officer:
- Perform data analysis to evaluate safety signals and write up analysis results.
- Author Safety Assessment Reports and other safety documents and regulatory responses
- Document work in the safety information management system (SIMS)
- Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross-functional decision-making body
- Preparation, writing and review of safety portions of aggregate reports
- Review clinical trial documents and provide input with regards to safety eg, study protocols, informed consent forms, safety related data collection forms)
- Attend clinical trial team meetings
- Aggregate review of Adverse Events/Serious Adverse Events from clinical trials
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
"This posting is for Contingent Worker, not an FTE"