Macleods Pharma Hiring for Pharmacovigilance Roles

Macleods Pharma Hiring for Pharmacovigilance Roles in Mumbai | B.Pharm, M.Pharm, Pharm.D | 2–5 Years Experience Required

Explore regulatory writing and drug safety jobs at Macleods Pharma. Openings available for PADER Author, Signal Detection Analyst, and ICSR Specialist in Andheri East, Mumbai. Only experienced candidates with B.Pharm, M.Pharm, or Pharm.D qualification can apply.

Macleods Pharma is inviting experienced professionals for pharmacovigilance roles in Mumbai, including PADER authoring, signal detection, and ICSR submission. Candidates with 2 to 5 years of relevant experience are encouraged to apply.

Pharmacovigilance Opportunities at Macleods Pharma, Mumbai

Looking to accelerate your pharmacovigilance career in a leading pharmaceutical organization? Macleods Pharma is offering excellent opportunities for experienced drug safety professionals in Mumbai.

If you’re qualified in pharmacy or life sciences and have strong experience in pharmacovigilance writing, signal detection, or ICSR submissions, these roles are ideal for you.

Open Roles & Key Details

Pharmacovigilance Specialist – PADER Author

• Location: Andheri East, Mumbai
• No. of Positions: 1
• Experience Required: Minimum 2 years
• Qualification: B.Pharm, M.Pharm, Pharm.D

Responsibilities:

• Draft and review Periodic Adverse Drug Experience Reports (PADERs)
• Ensure compliance with FDA regulations (21 CFR 314.80 & 600.80)
• Utilize safety databases (Argus/ARISg) for data analysis
• Collaborate with medical, regulatory, and safety teams
• Maintain knowledge of global PV regulations (ICH, GVP)

Signal Detection Analyst – Pharmacovigilance Department

• Location: Andheri, Mumbai
• No. of Positions: 1
• Experience Required: 2–5 years
• Qualification: B.Pharm, M.Pharm, Pharm.D

Responsibilities:

• Perform signal detection, risk assessment & cumulative case reviews
• Evaluate data using EVDAS and other safety tools
• Draft risk documents including Signal Detection Reports, PSURs, RMPs, and PADERs
• Conduct literature reviews & safety surveillance
• Ensure quality & regulatory compliance in pharmacovigilance activities

ICSR Submission Expert

• Location: Andheri, Mumbai
• No. of Positions: 1
• Experience Required: 2–4 years
• Qualification: B.Pharm, M.Pharm, Pharm.D

Responsibilities:

• Submit ICSR reports to EMA, USFDA, MHRA, and other global authorities
• Perform ARGUS case checks (listedness, seriousness, expectedness)
• Manage global reportability assessments and case reconciliation
• Respond to regulatory and internal safety queries
• Ensure compliance with global PV agreements and systems

Application Process

Interested candidates should send their updated resume to: adityab@macleodspharma.com

Note: Freshers are not eligible. Only candidates with relevant experience in pharmacovigilance roles will be considered.

Why Join Macleods Pharma?

• Fast-growing global pharmaceutical company
• Opportunity to work on complex and impactful PV projects
• Exposure to regulatory writing, safety surveillance & international submissions
• Growth-oriented environment with structured SOPs and quality systems

Summary Table

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs