Macleods Pharmaceuticals Ltd. has announced a job opportunity in its Pharmacovigilance Department for an experienced professional specializing in Safety Variations at its R&D operations in Andheri, Mumbai.
The position is suitable for candidates with 3 to 5 years of pharmacovigilance experience and an educational background in M.Pharm, B.Pharm, BDS, or BHMS.
The role primarily involves monitoring international regulatory safety updates, reviewing and updating SmPC and PIL documents for Europe and the UK, coordinating with Regulatory Affairs (RA), and identifying safety-related changes that require regulatory action.
Macleods Pharmaceuticals is a global pharmaceutical company headquartered in Mumbai, with operations and pharmaceutical activities across multiple international markets.
Job Highlights
| Category | Details |
|---|---|
| Company | Macleods Pharmaceuticals Ltd. |
| Job Role | Pharmacovigilance – Safety Variations |
| Department | Pharma Covigilance / Drug Safety |
| Experience | 3–5 Years |
| Qualification | M.Pharm, B.Pharm, BDS, BHMS |
| Location | Andheri, Mumbai, Maharashtra |
| Work Area | R&D |
| Employment Type | Full-Time |
| Freshers | Not eligible |
| Application Email | adityab@macleodspharma.com |
Macleods Pharmacovigilance Job Responsibilities
Selected candidates will be responsible for activities related to pharmacovigilance safety variations, regulatory safety updates, product information review, and coordination with Regulatory Affairs.
Key responsibilities include:
- Update Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) for European and UK markets based on applicable safety and regulatory requirements.
- Monitor regulatory communications and safety-related updates from agencies and regulatory bodies such as:
- European Medicines Agency (EMA)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- European Commission (EC)
- Heads of Medicines Agencies (HMA)
- Track safety-related regulatory developments arising from sources and processes such as PRAC, CMDh, CHMP, and safety signals.
- Coordinate with the Regulatory Affairs (RA) department regarding innovator information, common text, regulatory requirements, and queries.
- Review and monitor regulatory updates that may result in safety-related changes to product information.
- Conduct searches for country-specific innovator/reference product information.
- Regularly compare and review European and UK SmPC/PIL documents according to applicable SOPs.
- Identify changes that require regulatory filing or implementation.
- Update the Regulatory Safety Information (RSI) based on identified safety changes.
- Communicate identified changes and relevant information to the Regulatory Affairs team for further action.
Required Qualifications
Candidates applying for this Macleods Pharmacovigilance job should have one of the following qualifications:
- M.Pharm
- B.Pharm
- BDS
- BHMS
Candidates should have 3–5 years of relevant professional experience in pharmacovigilance, drug safety, regulatory safety information, safety variations, or closely related pharmaceutical functions.
Preferred Skills
Experience or familiarity with the following areas can be relevant to the role:
- Pharmacovigilance
- Safety Variations
- Regulatory Safety Information
- SmPC and PIL review
- European regulatory requirements
- UK regulatory requirements
- EMA regulatory updates
- MHRA regulatory updates
- PRAC recommendations
- CMDh communications
- CHMP-related safety information
- Regulatory Affairs coordination
- Product information comparison
- Safety signal-related regulatory changes
- Innovator/reference product research
- SOP-based document review
Who Can Apply?
This opportunity is intended for experienced pharmacovigilance professionals with 3–5 years of experience.
Freshers are specifically requested not to apply for this position.
Candidates with experience in pharmacovigilance safety variations, regulatory safety information, SmPC/PIL review, European/UK product information, or PV–RA coordination may find the role particularly relevant to their background.
Salary Information
Employer-confirmed salary: Not disclosed in the provided vacancy.
For informational purposes, publicly available salary data for pharmacovigilance positions at Macleods and comparable experience levels indicate a broad range in the market. One published salary dataset lists Macleods Pharmacovigilance Officer salaries at approximately ₹3.5 lakh–₹6.1 lakh per year for 4–8 years of experience.
For this specific 3–5 year Safety Variations role, Pharmabharat estimates a potential market range of approximately ₹4 lakh–₹7 lakh per annum. This is an editorial market estimate and is not confirmed by Macleods Pharmaceuticals.
Why This Role May Be Relevant for Pharmacovigilance Professionals
A Safety Variations position provides exposure to the intersection of pharmacovigilance and regulatory affairs, particularly where safety information needs to be reflected in product information.
Professionals in this area can gain practical experience with:
- International regulatory safety requirements
- European and UK product information
- SmPC/PIL lifecycle management
- Regulatory safety updates
- PV and RA collaboration
- Safety signal implementation
- Regulatory document comparison
- Country-specific product information
- Safety-related regulatory submissions
How to Apply for Macleods Pharmacovigilance Jobs
Interested and eligible candidates can send their updated CV/resume directly to the recruitment contact provided for this vacancy.
Application Email:
adityab@macleodspharma.com