Macleods Pharmaceuticals has announced a new hiring opportunity for experienced pharmacovigilance professionals in the XEVMPD and Europe/UK safety variation domain. The opening is based at the R&D division in Andheri, Mumbai, and is ideal for candidates with 1–2 years of experience in XEVMPD updates, SmPC/PIL review, and EU pharmacovigilance compliance.
Candidates with experience in Europe and UK safety variation processes, regulatory intelligence, and EudraVigilance database management are encouraged to apply.
Job Overview
| Details | Information |
|---|---|
| Job Role | XEVMPD Executive / Pharmacovigilance Associate |
| Department | Pharma Covigilance |
| Experience Required | 1–2 Years |
| Qualification | B.Pharm, M.Pharm (Pharmacology) |
| Job Location | Andheri, Mumbai |
| Employment Type | Full-Time |
| Industry | Pharmacovigilance / Regulatory Affairs |
Key Responsibilities
The selected candidate will work on Europe and UK safety variation activities and XEVMPD management processes. Key responsibilities include:
- Updating SmPC and PIL documents based on innovator comparison and authority updates including PRAC, CMDh, CHMP, and signal-related changes.
- Monitoring EMA, MHRA, EC Decision, and HMA regulatory websites for latest pharmacovigilance and safety updates.
- Coordinating with Regulatory Affairs teams for common text alignment and query resolution.
- Reviewing and comparing country-specific innovator labels and translations.
- Tracking safety variation submissions with Europe Regulatory teams.
- Managing XEVMPD updates in the EudraVigilance database.
- Maintaining safety variation trackers and XEVMPD trackers as per SOP requirements.
- Resolving safety-related queries from vendors, LRPs, QPPV, and regulatory authorities.
- Updating SOPs based on guideline revisions and regulatory changes.
- Archiving and maintaining compliance documentation related to safety variation activities.
Required Skills
Candidates applying for this pharmacovigilance job in Mumbai should have:
- Knowledge of XEVMPD and EudraVigilance systems
- Understanding of GVP Modules and ICH GCP Guidelines
- Familiarity with MHRA UK guidelines and EU regulatory processes
- Experience in safety variation management
- Strong documentation and communication skills
- Ability to perform regulatory intelligence searches independently
Educational Qualification
Applicants must possess one of the following qualifications:
- B.Pharm
- M.Pharm (Pharmacology)
Salary and Benefits
The expected salary for this XEVMPD job in Mumbai is approximately ₹4.5 LPA – ₹7 LPA, depending on experience and regulatory expertise.
Additional benefits may include:
- Exposure to Europe and UK pharmacovigilance operations
- Career growth in global regulatory affairs
- Opportunity to work with cross-functional R&D and PV teams
- SOP and compliance training
How to Apply
Interested and eligible candidates can send their updated CV to:
Email: adityab@macleodspharma.com
Important: Mention “XEVMPD” in the email subject line while applying.
Note: Freshers are not eligible for this position. Only experienced candidates should apply.