Pharmacovigilance Physician

·         Medical evaluation of adverse event reports, including but not limited to
all serious and expedited reports and all pregnancy reports

·         Preparation of IND letters to investigators (SUA summaries)

·          Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports

·         Provide medical input for ad-hoc queries as requested

·          Participate in signal detection efforts, e.g. strategy meetings and periodic
reports and structured surveillance programs and other medical/scientific
meetings

·         Review aggregate reports such US Periodic Reviews and non-serious
line listings of events on a weekly basis to assess correct seriousness
classification

·         The primary decision making responsibility centers on the assessing the medical significance of the individual case safety report

·         The PVP evaluates each adverse event report for seriousness, labelledness,
corrects coding of the adverse event and ensures that all medically
relevant information from source documents are included in the
applicable reports

·         When necessary, the PVP requests the Safety associate to inquire for additional relevant information, per SOP and will discuss cases of particular interest with the PV Physician Team Lead, Post-Marketing Safety Expert, and/or safety surveillance physician

·         The PVP, in collaboration with the project physician, prepares an SUA
summary (letter to the investigator) for serious, unlisted, associated
adverse events occurring in specified IND trials

·         In performing these activities, the PVP is responsible for following international
pharmacovigilance regulations, company and department SOPS and department
and function working practices.

Education: MD

Number of Years Work Experience Required:   3-5

·         Medical evaluation of adverse event reports, including but not limited to
all serious and expedited reports and all pregnancy reports

·         Preparation of IND letters to investigators (SUA summaries)

·          Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports

·         Provide medical input for ad-hoc queries as requested

·          Participate in signal detection efforts, e.g. strategy meetings and periodic
reports and structured surveillance programs and other medical/scientific
meetings

·         Review aggregate reports such US Periodic Reviews and non-serious
line listings of events on a weekly basis to assess correct seriousness
classification

·         The primary decision making responsibility centers on the assessing the medical significance of the individual case safety report

·         The PVP evaluates each adverse event report for seriousness, labelledness,
corrects coding of the adverse event and ensures that all medically
relevant information from source documents are included in the
applicable reports

·         When necessary, the PVP requests the Safety associate to inquire for additional relevant information, per SOP and will discuss cases of particular interest with the PV Physician Team Lead, Post-Marketing Safety Expert, and/or safety surveillance physician

·         The PVP, in collaboration with the project physician, prepares an SUA
summary (letter to the investigator) for serious, unlisted, associated
adverse events occurring in specified IND trials

·         In performing these activities, the PVP is responsible for following international
pharmacovigilance regulations, company and department SOPS and department
and function working practices.

Education: MD

Number of Years Work Experience Required:   3-5