Pharmacovigilance Safety Scientist

ProPharma is seeking a Pharmacovigilance Safety Scientist to support the activities in the Benefit Risk group by ensuring day-to-day operational activities are completed. The role involves authoring aggregate reports, risk management plans, and signal management reports, as well as performing literature searches and data extraction.

Requirements

• Authoring of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
• Authoring of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
• Authoring of Signal Management Reports.
• Performing literature search and validity check for the aggregate reports.
• Reconciliation of relevant process trackers.
• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
• Generation of Line Listings (LL) from safety database
• Providing reliable support for high priority Ad-hoc activities.