Macleods Pharmaceuticals is inviting applications from experienced Pharmacovigilance professionals for PSMF roles at its R&D division in Andheri, Mumbai. Candidates with 3–7 years of experience in PSMF activities, European pharmacovigilance compliance, and regulatory safety documentation are encouraged to apply.
This Pharmacovigilance job in Mumbai is ideal for M.Pharm (Pharmacology) candidates looking to build a long-term career in global drug safety operations, regulatory compliance, and PSMF management for Europe, UK, and ROW markets.
Job Overview
- Company: Macleods Pharmaceuticals
- Department: Pharmacovigilance – R&D
- Role: PSMF Executive / Pharmacovigilance Professional
- Experience Required: 3–7 Years
- Location: Mumbai (Andheri)
- Qualification: M.Pharm (Pharmacology)
- Industry: Pharmaceutical / Drug Safety / Pharmacovigilance
Key Responsibilities
Candidates selected for the PSMF Pharmacovigilance role at Macleods Pharma will be responsible for:
- Drafting and reviewing PSMF documents for Europe, UK, and ROW regions
- Coordinating with stakeholders for data collection and maintaining PSMF trackers
- Updating SmPC and PIL documents based on PRAC, CMDh, CHMP, Signal, and regulatory updates
- Monitoring EMA, MHRA, EC Decision, and HMA websites for new safety and regulatory updates
- Collaborating with Regulatory Affairs teams regarding innovator labels, common text, and safety queries
- Reviewing and comparing SmPC/PIL documents regularly as per SOP requirements
- Handling safety-related queries from vendors, LRPs, QPPV, and regulatory authorities
- Maintaining safety variation trackers and documentation archives
- Updating SOPs based on revised pharmacovigilance guidelines and GVP module changes
- Managing safety variation approval documents, RSI documents, grant letters, and email records
Required Skills and Knowledge
Applicants should possess:
- Strong knowledge of PSMF activities and Pharmacovigilance operations
- Expertise in GVP Modules, MHRA UK guidelines, and ICH GCP guidelines
- Understanding of Europe and country-specific regulatory requirements
- Experience with safety variation management and regulatory document review
- Excellent written and verbal communication skills
- Ability to manage multiple pharmacovigilance activities simultaneously
Eligibility Criteria
Educational Qualification
- M.Pharm in Pharmacology
Experience
- Minimum 3 years and maximum 7 years in Pharmacovigilance / PSMF operations
Why Join Macleods Pharma?
Macleods Pharmaceuticals is one of India’s leading pharmaceutical companies with a strong global presence across regulated and semi-regulated markets. Working in the Pharmacovigilance and PSMF team offers exposure to:
- European Pharmacovigilance systems
- Global regulatory compliance
- Safety documentation management
- International health authority interactions
- Career growth in drug safety and regulatory affairs
How to Apply
Interested and eligible candidates can share their updated CV directly via email.
Email ID: Application for PSMF Pharmacovigilance Role –