Pharmacovigilance Officer

Why This Role Matters
Pharmacovigilance professionals play a critical role in safeguarding public health by monitoring, evaluating, and reporting drug safety data. Aggregate safety reports such as PADERs, PSURs, PBRERs, and Risk Management Plans (RMPs) are essential regulatory documents that ensure ongoing benefit-risk evaluation of medicinal products.
As an Officer – Pharmacovigilance at Unichem Laboratories, you will contribute directly to global drug safety compliance, regulatory reporting accuracy, and adherence to international standards such as FDA, ICH-GCP, and GVP guidelines. This role is ideal for pharmacy professionals aiming to build a strong career in drug safety and regulatory science.

Job Description
Unichem Laboratories is hiring for the position of Officer – Pharmacovigilance (Aggregate Report Drafting) in Mumbai. This is a full-time, permanent opportunity for professionals with 1–6 years of pharmacovigilance experience, particularly in aggregate safety reporting.
The selected candidate will be responsible for drafting, reviewing, and maintaining periodic safety reports and ensuring compliance with global regulatory requirements. The role also involves supporting pharmacovigilance operations, conducting training sessions, and collaborating with Medical Affairs and other internal stakeholders.

Key Responsibilities

• 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 pharmacovigilance-related inquiries
This position provides comprehensive exposure to global drug safety regulations and aggregate report drafting processes.

Eligibility Criteria

Educational Qualification:
• B.Pharm (Bachelor of Pharmacy)
• M.Pharm (Any Specialization Preferred)

Experience:
• 1–6 years of pharmacovigilance experience
• Hands-on experience in aggregate safety report drafting preferred

Desired Skills & Competencies

• Strong understanding of international regulatory requirements including FDA, ICH-GCP, and GVP Modules
• Knowledge of EU Clinical Trial Directive
• Experience in pharmacovigilance aggregate report drafting
• Excellent written and verbal communication skills
• Strong analytical and decision-making abilities
• High attention to detail in drug safety documentation
• Ability to work effectively in dynamic, cross-functional teams

Salary & Benefits

Compensation: Competitive salary aligned with industry standards, based on experience and expertise.
Additional Benefits:
• Opportunity to work with a reputed pharmaceutical organization
• Exposure to global regulatory frameworks (FDA, ICH, GVP)
• Strong career progression in pharmacovigilance and drug safety
• Corporate exposure in a Mumbai-based pharmaceutical setup
• Professional development in regulatory documentation and compliance

Company Overview
Unichem Laboratories is a well-established pharmaceutical company engaged in the development, manufacturing, and marketing of pharmaceutical formulations and active pharmaceutical ingredients.
The organization emphasizes regulatory compliance, quality standards, and global pharmacovigilance practices. Working at Unichem offers professionals exposure to structured drug safety systems and international reporting standards.

FAQs

Q: Is aggregate report drafting experience mandatory?
Experience in drafting PADERs, PSURs, PBRERs, or RMPs is highly preferred for this role.

Q: What level of experience is required?
Candidates with 1–6 years of pharmacovigilance experience are eligible to apply.

Q: Is this role focused only on documentation?
The primary focus is aggregate report drafting, but it also includes PV compliance monitoring, training, and coordination with Medical Affairs.

Q: Where is the job location?
The position is based in Mumbai.

Application Tips

• Highlight specific aggregate reports you have drafted or reviewed
• Mention exposure to FDA, ICH-GCP, and GVP guidelines
• Showcase analytical skills and experience in benefit-risk evaluation
• Demonstrate familiarity with SOP-based environments
• Prepare to discuss regulatory inspection or audit exposure