Pharmacovigilance Specialist

We are seeking a skilled Pharmacovigilance Specialist to join our dynamic team and contribute to the safe management of medicines.

• Perform local safety case receipt, processing, data entry, quality control tracking, and ICSR follow-up of all safety information received for clients in accordance with agreed timelines.
• Manage generic or client-specific email boxes as appropriate.
• Register, triage, assign, and coordinate the processing of vigilance cases.
• Follow up with local reporters as needed.
• Respond to queries from clients and reporters.
• Carry out periodic reconciliations to confirm proper handling of all vigilance reports for clients.
• Support and contribute to local pharmacovigilance activities performed by the department as needed.
• Participate in audits and inspections, and implement resulting action plans.

• Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or a related science field, or equivalent experience.
• 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
• Experience working to deadlines.
• Experience in client communications.
• Knowledge of US and EU PV regulations.
• Pharmaceutical background with a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
• Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

• Excellent organizational and interpersonal skills.
• Ability to work well within a team.
• Accountability and autonomy with assigned tasks.
• Process-oriented with good attention to detail.
• Effective written and verbal communication skills to explain complex concepts and address queries.
• Flexibility and adaptability to handle a dynamic workload.
• Ability to work well under pressure and meet deadlines.