Pharmacovigilance Specialist

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

Performs day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, 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 PV 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, including 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-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 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.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Experience: Minimum 4+ years of experience in PV case processing.
• Case Types: Should have worked in Clinical Trial and PMS cases.
• Database Experience: Should have working experience in Argus Database.

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.
• Good oral and written communication skills, including paraphrasing skills.
• Good command of English and ability to translate information into local language where required.
• Computer literate with the ability to work within multiple databases.
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel).
• Understanding the importance of and compliance with procedural documents and regulations.
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.
• Strong attention to detail.
• Ability to maintain a positive and professional demeanor in challenging circumstances.
• Ability to work effectively within a team to attain a shared goal.

Application Instructions

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Company Information

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