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 Responsible 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.
Robust 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