Safety Spec

Summarized Purpose:
Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment
and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection,
monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and
performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case
review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with
various parties such as: project team members, client contacts, investigators, and adverse event/
reporters, and third party vendors. May assist in the preparation of departmental and project-specific
procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
Essential Functions
Performs day-to-day PV activities. May participate in on-call duties for specific
projects to ensure 24-hr coverage for...

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