Total Exp - 10+Years

Education - BDS

Location - Gurgaon

Immediate joiners only

- BDS qualification with approximately 10 years of experience in Pharmacovigilance/Drug Safety.
- Strong experience in management, medical review, and assessment of Adverse Events (AE) and Serious Adverse Events (SAE).
- Hands-on experience in signal detection, signal evaluation, signal management, and safety surveillance activities.
- Experience in benefit-risk assessment and safety risk evaluation throughout the product lifecycle.
- Authoring, review, and management of aggregate safety reports including PSUR/PBRER, DSUR, and other periodic safety reports.
- Ability to perform medical assessment, causality assessment, and safety data analysis.
- Good understanding of global pharmacovigilance regulations, GVP, and regulatory reporting requirements.
- Experience in end-to-end pharmacovigilance support across post-marketing and/or clinical development programs.
- Ability to independently manage safety deliverables from intake through evaluation, reporting, and regulatory submission support.




- Experience in direct client engagement, stakeholder management, and participation in client governance meetings.
- Ability to act as the primary client-facing safety lead and provide strategic recommendations on safety-related matters.
- Collaborate effectively with Medical Affairs, Clinical, Regulatory, and Quality teams.
- Review safety trends and identify potential safety concerns or emerging risks.
- Ensure compliance with applicable SOPs, regulatory requirements, and quality standards.
- Support audits, inspections, CAPA activities, and regulatory inquiries as required.
- Strong analytical, medical writing, and communication skills.
- Ability to work independently with minimal supervision and drive projects to completion.
- Proactive, detail-oriented professional with robust problem-solving and decision-making capabilities.
- Experience in mentoring junior team members and supporting operational excellence initiatives

📌 Senior Pharmacovigilance Specialist (BDS) - Immediate joiner (Gurugram)
🏢 WNS
📍 Gurugram