Analyst, PV

About the Role

Analyst - PV

Key Responsibilities

• Adverse Event Case Processing:
• Data entry of adverse event reports into the PV database.
• Seriousness assessment and causality assessment of adverse event reports.
• Identification and escalation of issues in case processing that may result in submission delays.
• Compliance with internal and external timelines for managing adverse events and product complaint case processing, and case submission processes.
• Validation of data entry against source document(s) and call notes.
• Assessment of adverse event reports for seriousness, reportability, and causality.
• Self-review of all data for completeness, correctness, and quality.
• Ensuring cases are complete, accurate, and ready for submission to appropriate regulatory authorities.
• Determination of needed follow-up information.
• Meeting expected productivity and quality standards.
• Active participation in team meetings.
• Performing other duties as assigned.

Requirements & Tech Stack

• Basic knowledge of medical terminologies and common medical terms relevant to pharmacovigilance and adverse event reporting.
• Effective verbal and written communication skills to liaise with internal and external stakeholders.
• Ability to work effectively on multiple products and manage priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers, and relevant stakeholders.
• Capability of adhering to applicable, global, and local regulatory requirements.
• Skill in using multiple databases.
• Ability to support during high volumes and flexibility to work extended hours when required.
• Self-motivated, flexible, and receptive to changes.
• Understanding of pharmacovigilance regulations.

Qualifications

• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience.
• M. Pharm with Pharmacovigilance Experience.
• Preferred: 0-2 years of pharmacovigilance experience.