Key Responsibilities:
- Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment and driven by strict timelines.
- PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information.
- Coordinates and performs PV activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities.
- Collaborates with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
- Assists in preparing departmental and project-specific procedures and processes, prepares for and attends 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-hour coverage for intake of cases from investigative sites.
- Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
- Maintains medical understanding of applicable therapeutic areas and disease states.
- Reviews cases entered for quality, consistency, and accuracy, including peer report reviews.
- Prepares and maintains regulatory safety reports.
- Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations.
- Mentors less experienced staff.
Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience (comparable to 2+ years) that provides the knowledge, skills, and abilities to perform the job.
- In some cases, an equivalency of education, training, and/or directly related experience will be considered.
Knowledge, Skills, and Abilities:
- General understanding of pathophysiology and the disease process.
- Detailed knowledge of relevant therapeutic areas as required for processing AEs.
- Strong critical thinking and problem-solving skills.
