Pharmacovigilance and Safety

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.

IND124

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