Umedica Labs is inviting applications for the position of Executive / Sr. Executive – Pharmacovigilance Coordinator at its Navi Mumbai, Maharashtra location. This is an excellent opportunity for experienced pharmacovigilance professionals with expertise in global safety reporting, regulatory compliance, and risk management activities.
Candidates with 7-9 years of experience in Pharmacovigilance or Regulatory Affairs and a strong understanding of global PV regulations across the US, UK, EU, Australia, and Canada are encouraged to apply.
Job Details
- Position: Executive / Sr. Executive – Pharmacovigilance Coordinator
- Company: Umedica Labs
- Location: Navi Mumbai, Maharashtra, India
- Experience Required: 7-9 Years
- Qualification: Bachelor’s or Master’s Degree in Pharmacy (B.Pharm/M.Pharm)
- Industry: Pharmaceuticals / Pharmacovigilance
- Employment Type: Full-Time
Key Responsibilities
The selected candidate will be responsible for:
- Managing safety reporting obligations across approved products in regulated markets including the US, UK, EU, Australia, and Canada.
- Preparing and submitting periodic safety reports such as PSURs, PBRERs, and DSURs within regulatory timelines.
- Maintaining and updating the Pharmacovigilance System Master File (PSMF) and Risk Management Plans (RMPs).
- Reviewing and updating product labeling for safety consistency across multiple markets.
- Uploading and maintaining product labeling information on eMC (UK) and DailyMed (US).
- Coordinating pharmacovigilance reporting requirements across six regulated markets with different formats and timelines.
- Ensuring consistency and accuracy of safety documentation.
- Supporting growing pharmacovigilance obligations associated with new product approvals.
- Acting as the primary contact for client requests related to safety data, reports, and summaries.
- Supporting due diligence activities for licensing opportunities by preparing regulatory safety sections.
- Establishing and maintaining Safety Data Exchange Agreements (SDEAs).
- Ensuring all PV documentation remains inspection-ready.
- Conducting annual internal mock reviews and closing compliance gaps.
- Supporting regulatory inspections by agencies including FDA, EMA, MHRA, TGA, and Health Canada.
Required Qualifications and Skills
- B.Pharm, M.Pharm
- 7-9 years of experience in Pharmacovigilance or Regulatory Affairs
- Strong knowledge of global pharmacovigilance regulations and reporting requirements
- Experience with PSMF, RMP, PSUR, PBRER, DSUR, and SDEAs
- Excellent organizational and project management skills
- Strong communication and client coordination abilities
- High attention to detail and documentation management skills
- Ability to handle multiple regulatory deadlines across global markets
Why Join Umedica Labs?
- Opportunity to work on global pharmacovigilance operations
- Exposure to multiple international regulatory agencies and reporting requirements
- Involvement in strategic safety and compliance activities
- Career growth in global drug safety and regulatory affairs
- Collaborative environment with opportunities to support licensing and inspection activities
How to Apply
Interested candidates can apply through the company career portal or share their updated resume directly via email:
Email: vaishnavi.k@umedicalabs.com
Applicants are advised to highlight their experience in global safety reporting, periodic reports, PSMF, RMP management, and regulatory inspection support while applying.
