Are you a B.Pharm or M.Pharm graduate with experience in pharmacovigilance aggregate report drafting? Here’s an excellent opportunity to work as an Officer – Pharmacovigilance (Aggregate Report Drafting) with Unichem Laboratories in Mumbai.
This full-time, permanent role is ideal for professionals with 1–6 years of pharmacovigilance experience, particularly in preparing PADERs, PSURs, PBRERs, and Risk Management Plans (RMPs). If you have strong knowledge of FDA, ICH GCP, and GVP guidelines, this role aligns well with your career in drug safety and regulatory compliance.
📌 Job Overview
- Role: Officer – Pharmacovigilance (Aggregate Report Drafting)
- Location: Mumbai, Maharashtra
- Experience: 1–6 Years
- Qualification: B.Pharm / M.Pharm
- Industry: Pharmaceutical & Life Sciences
- Employment Type: Full-Time, Permanent
🔬 Key Responsibilities
The Pharmacovigilance Officer will:
- Support execution of pharmacovigilance (PV) activities.
- Prepare and maintain PV documents, SOPs, and Work Instructions (WIs).
- Draft and review aggregate safety reports including:
- Periodic Adverse Drug Experience Reports (PADERs)
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Risk Management Plans (RMPs)
- Ensure compliance with company SOPs and global regulatory requirements.
- Monitor regulatory authority websites for safety updates and compliance changes.
- Provide accurate responses to medical information queries.
- Conduct PV training sessions for internal teams, manufacturing plants, and vendors.
- Support Medical Affairs in handling pharmacovigilance-related inquiries.
This role offers strong exposure to global pharmacovigilance regulations, safety reporting, and aggregate report drafting processes.
🎯 Desired Skills & Competencies
- Strong understanding of international regulatory requirements:
- FDA
- ICH GCP
- GVP Modules
- EU Clinical Trial Directive
- Experience in pharmacovigilance aggregate report drafting
- Excellent written and verbal communication skills
- Strong analytical and decision-making abilities
- Attention to detail in drug safety documentation
- Ability to work effectively in dynamic team environments
🎓 Educational Qualification
- UG: B.Pharm (Bachelor of Pharmacy)
- PG: M.Pharm (Any Specialization Preferred)
Candidates with hands-on experience in drug safety reporting and pharmacovigilance documentation will have an advantage.
💼 Why Apply for This Pharmacovigilance Job?
- Opportunity to work with a reputed pharmaceutical organization
- Exposure to global regulatory frameworks (FDA, ICH, GVP)
- Strong career growth in pharmacovigilance and drug safety
- Mumbai-based corporate exposure
This pharmacovigilance officer role is particularly suitable for professionals aiming to build long-term expertise in aggregate safety report drafting and regulatory compliance.
📩 How to Apply
