PV Associate/Sr PV

Key Responsibilities

• Review and process safety events (pre-marketing and post-marketing) according to project-specific procedures.
• Analyze abstracts and full articles to identify safety information for both marketed and investigational products.
• Generate and ensure the accuracy of data listings from the safety database.
• Complete adverse event follow-ups via writing or phone, adhering to client requirements.
• Maintain safety tracking systems for accuracy and quality, supporting the development of the Safety Management Plan.
• Assist in creating post-marketing safety documents, such as PSMF, RMP, and PBRER.
• Liaise with investigational sites, reporters, and Sponsors regarding safety issues.
• Support the generation of aggregated safety reports, including Development Safety Update Reports and IND Annual Reports.
• Assist with interim data analysis for DMC reviews and maintain quality control in the safety database.
• Contribute to signal detection and risk management activities alongside the Safety Scientist.
• Support audits and inspections for assigned projects and respond to medical information inquiries.

Your Profile

• Experience in a Pharmaceutical or CRO environment.
• At least 1 year of experience in pharmacovigilance.
• Excellent verbal and written communication skills.
• Detail-oriented with strong organizational and time management skills.
• Ability to work effectively both independently and in a team across global settings.
• Fluent in written and verbal English.