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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

Red Flags:
  • 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

Interview process:
Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.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.
3KC Talent Acquisition Team
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