Pharmacovigilance Job at WNS
Are you ready to take your career in pharmacovigilance to the next level? The role of Senior Pharmacovigilance Specialist at WNS offers a unique opportunity to engage with cutting-edge safety practices in the healthcare industry. This Pharmacovigilance Job requires a strong background in managing pharmacovigilance activities, ensuring compliance with global regulations, and providing strategic safety recommendations. The ideal candidate will work closely with clients and collaborate with various teams to maintain high safety standards throughout the product lifecycle. If you have a passion for safety and compliance, this role is for you.
About WNS:
WNS is a global leader in business process management, providing a range of services across various industries, including healthcare, insurance, and travel. The company is headquartered in Mumbai, India, and operates in multiple countries, delivering innovative solutions to enhance operational efficiency and customer experience.
Job Details:
- Position: Senior Pharmacovigilance Specialist (BDS) – Immediate joiner
- Location: Gurugram, Haryana, India
- Total Experience: 10+ Years
- Education: BDS
- Joining Preference: Immediate joiners only
Job Description:
The Senior Pharmacovigilance Specialist will be responsible for managing pharmacovigilance activities, ensuring compliance with global regulations, and providing strategic recommendations on safety-related matters. The role involves engaging with clients, conducting medical assessments, and collaborating with various teams to maintain safety standards throughout the product lifecycle.
Key Responsibilities of the Pharmacovigilance Job:
- 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 strong problem-solving and decision-making capabilities.
- Experience in mentoring junior team members and supporting operational excellence initiatives.
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