Macleods Pharma is hiring for its Pharmacovigilance Department (Safety Variations – Europe Region, XEVMPD) at its R&D center in Andheri, Mumbai. This opportunity is ideal for candidates with 0–7 years of experience who want to work on global safety variation submissions, XEVMPD updates, and regulatory compliance.
Key Responsibilities
As a Pharmacovigilance Associate – Safety Variations, you will be responsible for:
- Updating SmPC and PIL for Europe/UK as per EMA PRAC, CMDh, CHMP, and signal requirements.
- Collaborating with the Regulatory Affairs team for safety variations.
- Monitoring regulatory updates and implementing safety-related changes.
- Reviewing and comparing SmPC/PIL documents regularly as per SOP.
- Communicating with QPPV, vendors, LRPs, and health authorities to resolve queries.
- Maintaining and updating the safety variation tracker.
- Managing RSI, approval documents, grant letters, and archiving.
- Updating XEVMPD after approvals, transfers, and safety variation submissions.
- Ensuring compliance with GVP modules, MHRA guidelines, ICH-GCP, and EU/local regulations.
Required Qualifications
- Education:
- M.Pharm (Pharmacology) or B.Pharm
- Experience:
- 0–1 year (1 position)
- 2–7 years (1 position)
- Skills:
- Strong knowledge of EU GVP guidelines, MHRA UK regulations, and ICH-GCP.
- Excellent written and verbal communication skills.
- Ability to manage multiple safety submissions and track regulatory updates.
Benefits of Joining
- Opportunity to work on global pharmacovigilance safety variations.
- Gain exposure to XEVMPD and European regulatory submissions.
- Be part of a leading pharmaceutical company with strong international presence.
- Career growth in drug safety and regulatory compliance.
How to Apply
Interested candidates can share their resume with the subject line “Application – Pharmacovigilance Safety Variations” to:
