Macleods Pharmaceuticals is inviting applications for experienced professionals in the SDEA (Safety Data Exchange Agreement) domain for its Pharmacovigilance Department at R&D, Andheri, Mumbai. Candidates with 2 to 5 years of experience in pharmacovigilance agreements, compliance, and global safety operations are encouraged to apply.
This Pharmacovigilance job opportunity is ideal for candidates looking to work on global SDEA management, regulatory compliance, partner reconciliation, PSMF support, and PV audits within a reputed pharmaceutical company.
Job Details
| Job Role | SDEA Executive / Specialist |
|---|---|
| Department | PharmaCovigilance |
| Experience | 2 to 5 Years |
| Location | Andheri, Mumbai |
| Qualification | M.Pharm, B.Pharm, BDS, BHMS |
| Industry | Pharmacovigilance / Pharma |
| Employment Type | Full Time |
Key Responsibilities
Candidates selected for the SDEA Pharmacovigilance role at Macleods Pharma will be responsible for:
- Managing global Safety Data Exchange Agreements (SDEA)
- Drafting, reviewing, negotiating, revising, and archiving SDEAs
- Ensuring compliance with EU, UK, USFDA, India, and ROW pharmacovigilance regulations
- Coordinating with internal teams including Safety, Quality, Regulatory, Legal, Clinical Research, Supply Chain, and Commercial departments
- Supporting SDEA implementation and compliance activities
- Conducting monthly reconciliation with SDEA partners
- Supporting PSMF Annex B and Annex C documentation
- Assisting in PV due diligence for acquisitions and divestments
- Participating in audits and regulatory inspections as SDEA SME
- Conducting pharmacovigilance training for ADR reporting
- Completing partner audit questionnaires and SDEA-related training activities
Required Skills for SDEA Jobs in Pharmacovigilance
Applicants should possess:
- Strong knowledge of global pharmacovigilance regulations
- Experience in SDEA lifecycle management
- Understanding of PV operations and commercial agreements
- Excellent communication and stakeholder management skills
- Strong organizational and time management abilities
- Experience handling regulatory authority expectations for SDEAs
Educational Qualification
Eligible qualifications include:
- M.Pharm
- B.Pharm
- BDS
- BHMS
Why Join Macleods Pharma?
Working with Macleods Pharmaceuticals offers professionals exposure to:
- Global pharmacovigilance systems
- International regulatory frameworks
- Cross-functional pharmaceutical operations
- Career growth in drug safety and compliance
- Advanced R&D and PV operations in India
How to Apply
Interested and eligible candidates can share their updated CV directly via email:
Email: adityab@macleodspharma.com
Candidates should mention “Application for SDEA Role” in the subject line while applying.