Appasamy is hiring an experienced PV Specialist (Pharmacovigilance Specialist) to oversee pharmacovigilance and medical device vigilance activities at its Chennai (Ambattur) location. This role is ideal for pharmacy professionals with hands-on experience in adverse event reporting, complaints handling, PMS activities, and global regulatory compliance.
If you are looking for PV Specialist jobs in Chennai, pharmacovigilance jobs in medical devices, or drug safety jobs in India, this opportunity offers strong career growth in a regulated, patient-safetyโfocused environment.
Key Responsibilities
Medical Device Vigilance (MDV)
- Collect, assess, and investigate adverse events, product malfunctions, and user complaints related to medical devices
- Ensure timely submission of MDV reports to regulatory authorities such as CDSCO, US FDA, and EU Competent Authorities
- Maintain documentation for FSCAs, recalls, and risk assessments
- Collaborate with Design, Manufacturing, and Quality Assurance teams for CAPA implementation
- Maintain vigilance SOPs and support regulatory, internal, and notified body audits
- End-to-end complaints handling and documentation
Pharmacovigilance โ Pharmaceutical Products
- Monitor, assess, and report ADRs from spontaneous reports, literature, clinical trials, and other sources
- Prepare and submit ICSRs, PSURs, and DSURs in compliance with global guidelines
- Perform signal detection, trend analysis, and riskโbenefit assessment
- Execute Post-Marketing Surveillance (PMS) activities
- Ensure compliance with global PV regulations and internal quality systems
Qualifications & Experience
- Education: Bachelorโs or Masterโs degree in Pharmacy (B.Pharm / M.Pharm)
- Experience: 1 to 6 years in Pharmacovigilance or Medical Device Vigilance
- Strong working knowledge of global PV & MV regulations
- Experience with complaints handling, audits, and regulatory submissions preferred
Why Join Appasamy?
- Exposure to both medical device vigilance and pharmaceutical pharmacovigilance
- Work in a regulated, compliance-driven environment
- Opportunity to collaborate with cross-functional quality and engineering teams
- Competitive salary aligned with industry standards
- Career growth in drug safety and medical device compliance
Job Location
Chennai โ Ambattur, Tamil Nadu
Salary (Indicative)
โน4,00,000 โ โน8,00,000 per annum (based on experience and skill set)
How to Apply
Interested candidates can apply by sending their updated CV to:
๐ง sethuraman.gopal@appasamy.com
๐ง careers@appasamy.com
