“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"