PV Associate/Sr PV

• Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) according to assigned tasks and project-specific procedures.
• Analyze abstracts and full articles to extract safety information for both pre and post-marketed products.
• Generate data listings from the safety database, ensuring data accuracy.
• Complete adverse event follow-ups via writing and/or phone, tailored to client requirements.
• Maintain and review relevant safety tracking systems for accuracy and quality, assisting with project file maintenance.
• Perform safety reviews of clinical and diagnostic data as part of case processing.
• Develop and maintain the Safety Management Plan, ensuring project consistency.
• Support post-marketing safety activities, including PSMF, RMP, and PBRER.
• Liaise with investigational sites, reporters, and sponsors regarding safety issues.
• Collaborate with ICON Medical Monitor, project managers, and other departments as needed.
• Assist in identifying out-of-scope activities in collaboration with the Pharmacovigilance Project Lead.
• Attend project team and Sponsor meetings, presenting safety processes as required.
• Support the generation of aggregated safety reports, including Development Safety Update Reports and Periodic Safety Update Reports.
• Maintain the safety database and ensure quality control of data entry.
• Aid in the creation and reconciliation of SAE/AE plans.
• Support signal detection and risk management activities.
• Propose solutions for procedural and technical challenges.
• Assist with audits and inspections as needed for assigned projects.
• Respond to and process medical inquiries related to adverse events and product complaints.

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 abilities.
• Fluent in written and verbal English.
• Ability to work effectively both independently and as part of a team across global teams