Pharmacovigilance and Safety
Location
Ridgefield, CT | United States
Job description
Pharmacovigilance and Safety
Provide services relating to adverse event reporting with a focus on the Final Review step of case processing and any other responsibilities typically associated with, but not limited to, the outlines and responsibilities detailed below.
- A scalable position requiring 20 - 40 hours per week.
- This position is Remote/Telecommute
Education:
- Must have MD/ DO
- Must have a Medical license (US or equivalent)
- Must have at least one year of post-license clinical experience.
Responsibilities of Contractor
- Provide personnel/resources qualified to meet deliverable expectations as more completely described in the Responsibilities and Deliverables set forth below.
- Along with Project Manager, review all timecards and any expense reimbursements for accuracy and adherence with policies.
Patient Safety & Pharmacovigilance Contract Physician Deliverables and Responsibilities:
- Responsible for assessing individual clinical trials and spontaneous case reports for medical review and regulatory reporting determination.
- Assessing seriousness, expectedness, and causality.
- Querying for additional medical information needed to understand, analyze, and assess the case reports.
- Writing individual case assessments.
- Interpreting aggregate safety data as needed.
- On an as needed basis, perform active phone follow-up on selected medically important cases on behalf of US Patient Safety & Pharmacovigilance (PSPV), in order to optimize safety data collection and analysis.
- Scalable position requiring 20 - 40 hours per week.
This position is necessary for GPV to meet its corporate responsibilities to ensure all pharmacovigilance/risk management activities are performed in accordance with standard operating procedures and within regulatory timelines.
Required Experience:
- 5+ years industry experience in pharmacovigilance/risk management and analysis of safety data.
- Clinical Medicine experience with more than 1+ year of patient care required.
- Excellent written & verbal communication skills.
- Experience performing medical review and assessment of individual case safety reports and expedited reporting required.
- General knowledge of medical computer programs.
- Ability to learn computer database programs
Oncology experience is highly preferred.
Job tags
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