Job Title: Pharmacovigilance Specialist – PADER Author
Department: Pharmacovigilance / Regulatory Writing
Location: Andheri East, Mumbai
Experience Required: Minimum 2 years in PADER drafting
Email: adityab@macleodspharma.com
Job Description
Macleods Pharmaceuticals is seeking an experienced Pharmacovigilance Specialist specializing in PADER (Periodic Adverse Drug Experience Reports) drafting to join our dynamic team in Andheri East, Mumbai. If you have a strong background in pharmacovigilance, regulatory writing, and FDA compliance, this could be the perfect opportunity for you!
Key Responsibilities:
- Draft, review, and finalize PADERs in compliance with FDA regulations (21 CFR 314.80 & 600.80).
- Analyze adverse event data from global safety databases (e.g., Argus, ARISg).
- Collaborate with safety physicians, regulatory affairs, and medical teams to ensure accurate reporting.
- Ensure adherence to ICH guidelines, GVP (Good Pharmacovigilance Practices), and company SOPs.
- Support regulatory inspections, audits, and submissions related to pharmacovigilance.
- Stay updated with evolving global pharmacovigilance regulations and industry trends.
Qualifications & Skills:
- Education: B.Pharm / M.Pharm / Pharm.D
- Experience: Minimum 2 years in PADER writing (Freshers should not apply).
- Strong knowledge of FDA, ICH, and EMA pharmacovigilance guidelines.
- Proficiency in safety databases (Argus, ARISg) and regulatory writing tools.
- Excellent scientific writing, data analysis, and communication skills.
About Macleods Pharmaceuticals
Macleods Pharmaceuticals is a leading Indian pharmaceutical company with a strong global presence. We specialize in high-quality, affordable generic medicines and are committed to patient safety and regulatory compliance. Our Pharmacovigilance Department plays a crucial role in ensuring drug safety and compliance with global standards.
Join us to be part of a growth-driven, innovation-focused team in the pharmaceutical industry!
How to Apply?
If you meet the qualifications and are interested in this PADER Author role, please email your updated resume to:
Note: Only candidates with 2+ years of PADER drafting experience will be considered. Freshers are requested not to apply.