Macleods Pharmaceuticals Ltd. is hiring an experienced professional for its Pharmacovigilance Department under the Safety Variations function.
The role is based in the company’s R&D function in Andheri, Mumbai, and requires experience in regulatory safety-related activities.
Candidates with 3–5 years of relevant experience in pharmacovigilance, regulatory safety variations, or related pharmaceutical functions can apply.
Eligible qualifications include M.Pharm, B.Pharm, BDS, and BHMS, while freshers are not eligible for this position.
Macleods Pharmaceuticals Pharmacovigilance Department: Safety Variations
Position Details
- Department: Pharmacovigilance
- Role: Safety Variations
- Function: R&D
- Experience: 3–5 Years
- Location: Andheri, Mumbai
- Qualification: M.Pharm / B.Pharm / BDS / BHMS
Eligibility & Qualifications
M.Pharm | B.Pharm | BDS | BHMS
Candidates should have 3–5 years of relevant experience. Freshers are not eligible for this role.
Macleods Pharmaceuticals Safety Variations: Roles & Responsibilities
SmPC & PIL Updates
- Update SmPC and PIL for Europe and the UK as per applicable requirements, including PRAC, CMDh, CHMP, Signal and other relevant regulatory requirements.
- Search regulatory websites for new updates from sources such as EMA, MHRA, EC decisions and HMA.
Regulatory & Interdepartmental Communication
- Coordinate with the Regulatory Affairs (RA) department regarding innovator information, common text and regulatory queries.
- Maintain effective interdepartmental communication for safety-related regulatory activities.
Regulatory Safety Monitoring
- Review and monitor regulatory updates related to safety changes.
- Identify relevant safety-related regulatory changes and assess their impact on product information.
Country-Specific Regulatory Review
- Search for country-specific innovator information and other relevant regulatory sources.
- Track applicable requirements for Europe and UK markets.
SmPC / PIL Review & RSI Updates
- Compare and review Europe and UK SmPC/PIL regularly as per the applicable SOP.
- Identify changes that need to be filed.
- Update the RSI and share the relevant information with the Regulatory Affairs team.
Macleods Pharmaceuticals Pharmacovigilance Role: Required Experience
Experience
3–5 Years
Candidates should have relevant experience in Pharmacovigilance, Safety Variations, regulatory safety activities, SmPC/PIL updates, or related pharmaceutical regulatory functions.
Freshers Eligibility
Freshers are not eligible for this position.
Macleods Pharmaceuticals R&D: Job Location
Work Location
Macleods Pharmaceuticals Ltd.
Andheri, Mumbai, Maharashtra
The position is part of the company’s R&D function and focuses on safety variations and regulatory activities for Europe and UK markets.
How to Apply
Interested and eligible candidates can share their updated resume with the recruitment contact:
Email: adityab@macleodspharma.com
Candidates should mention their relevant experience, current role and qualification clearly in their resume.
Important: Freshers should not apply for this role.
Jobs: Job Summary
| Company | Macleods Pharmaceuticals Ltd. |
| Vacancies | Pharmacovigilance – Safety Variations |
| Required Education | M.Pharm; B.Pharm; BDS; BHMS |
| Experience | 3–5 Years |