Job Description
Premier Research is seeking a Pharmacovigilance Physician II to join our Pharmacovigilance and Records Management team.
What You'll Be Doing:
- Conduct medical assessment of all safety related data (AEs, SAE, SUSAR, AESI, etc.) as per the project contract
- Ensure medical accuracy of case narratives, coding and medical sense of all cases and raise appropriate queries to expedite case closure
- Provide analysis of similar events (AOSE)
- Write safety sections, including benefit–risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports, and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission
- Review Safety Management Plans
- Ensure compliance with and adherence to all internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOP...