Pharmacovigilance

Why This Role Matters
Pharmacovigilance professionals handling ICSR QC and Final Review are critical to ensuring accuracy, compliance, and timely regulatory reporting. Their expertise directly impacts patient safety and global drug safety standards.

Job Description
An opportunity is open for experienced Pharmacovigilance professionals with 5–7 years of hands-on experience in case processing and ICSR QC/Final Review. The role is based in Pune and is suitable for immediate joiners only.

Key Features of the Role:
• Location: Pune
• Experience: 5–7 years
• Domain: Pharmacovigilance
• Specialization: ICSR QC / Final Review
• Immediate joiners preferred
• Freshers are not eligible

Responsibilities
• Perform ICSR Quality Control (QC) and Final Medical Review
• Ensure compliance with global pharmacovigilance standards
• Validate case accuracy, completeness, and regulatory timelines
• Review case narratives and coding
• Ensure adherence to client SOPs and regulatory requirements
• Collaborate with PV teams for case resolution

Required Qualifications
• Degree in Pharmacy, Life Sciences, or related field
• 5–7 years of Pharmacovigilance experience
• Strong experience in ICSR QC / Final Review

Experience and Skills:
• In-depth knowledge of PV case processing workflow
• Understanding of global regulatory guidelines (FDA, EMA, ICH)
• Strong analytical and attention-to-detail skills
• Experience in safety databases
• Good communication and documentation skills

Salary Insights
Salary not disclosed (market-competitive package expected for experienced PV professionals).

FAQs

Q1 Are freshers eligible?
No, only professionals with 5–7 years of relevant experience should apply.

Q2 Is case processing experience mandatory?
Yes, hands-on experience in ICSR QC/Final Review is required.

Q3 What is the location?
Pune.

Q4 Are immediate joiners preferred?
Yes, immediate joiners are preferred.

How to Apply
Interested candidates meeting the criteria can share their CV

Application Tips
• Clearly highlight ICSR QC / Final Review experience
• Mention safety databases worked on (e.g., Argus, ARISg)
• Specify total Pharmacovigilance experience
• Confirm notice period or immediate availability