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 intake of cases from investigative sites.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Maintains medical understanding of applicable therapeutic area and disease
states.
Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
Prepares and maintains regulatory safety reports.
Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.

Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.