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Global Pharmacovigilance Scientist – REMOTE - (JP9835)
Thousand Oaks, CA · Biotech/PharmaceuticalJob 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:
Day to Day Responsibilities:
Key Activities Applicable tasks may vary by product(s) assigned.
The PV Scientist Manager is responsible for the following:
o Author Safety Assessment Reports and other safety documents and regulatory responses
Red Flags:
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.
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 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.
Regards,
3KC Talent Acquisition Team