Global Pharmacovigilance Scientist – REMOTE - (JP9835)
Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Global Pharmacovigilance Scientist – REMOTE - (JP9835) Location: Thousand Oaks, CA. (100% REMOTE) Employment Type: Contract Business Unit: GPS Safety Management Duration: 6+ months (with likely extensions) Notes: Minimum of 5 years of experience within a pharmaceutical environment. Minimum Bachelor's in science related field, ideally with clinical expertise i.e., Nursing/Public Health/Pharmacy etc.
Posting Date: 03/02/2022
3 Key Consulting is hiring a Global Pharmacovigilance Scientist for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: The Global PV Scientist (GPvS) works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to Global Patient Safety (GPS).
Top 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:
o Perform data analysis to evaluate safety signals and write up analysis results. o 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
Experience limited to case management - review of individual case reports. Experience in Signal Detection and data analysis Review or aggregate data Writing of periodic reports
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.