Associate Safety Specialist

Fusion Market Research; Navi Mumbai, Pune District, Bengaluru; On-site; INR 300,000 - 600,000; Full time

Job summary

Fusion Market Research in Navi Mumbai is seeking a Pharmacovigilance Associate to handle adverse event reports, enter data into PV systems, and perform MedDRA/WHODrug coding. You will assess cases for seriousness and causality and ensure timely regulatory reporting in compliance with guidelines.

Ideal candidates hold a B.Pharm/M.Pharm/Pharm.D or life sciences degree, with basic PV knowledge and familiarity with ICH guidelines. Attention to detail and strict adherence to SOPs are essential.

Qualifications

• B.Pharm, M.Pharm, Pharm.D, B.Sc. (Life Sciences), or a related qualification.
• Basic knowledge of pharmacovigilance and drug safety.
• Understanding of adverse event reporting (ICSRs) and safety documentation.
• Knowledge of MedDRA coding and ICH guidelines is an advantage.

Responsibilities

• Receive, review, and process adverse event reports (ICSRs).
• Enter and maintain accurate safety data in pharmacovigilance databases.
• Perform medical coding using MedDRA and WHODrug.
• Assess cases for seriousness, expectedness, and causality as per guidelines.
• Follow up on missing or incomplete case information.
• Ensure timely reporting in compliance with regulatory requirements.
• Perform quality checks to maintain data accuracy and completeness.
• Follow company SOPs and applicable pharmacovigilance regulations.

Skills

Pharmacovigilance knowledge

Drug safety basics

Attention to detail

Education

B.Pharm

M.Pharm

Pharm.D

B.Sc. Life Sciences

Tools

MedDRA coding

WHODrug knowledge

Job description

Role & responsibilities

• Receive, review, and process adverse event reports (ICSRs).
• Enter and maintain accurate safety data in pharmacovigilance databases.
• Perform medical coding using MedDRA and WHODrug.
• Assess cases for seriousness, expectedness, and causality as per guidelines.
• Follow up on missing or incomplete case information.
• Ensure timely reporting in compliance with regulatory requirements.
• Perform quality checks to maintain data accuracy and completeness.
• Follow company SOPs and applicable pharmacovigilance regulations.

Preferred candidate profile

• B.Pharm, M.Pharm, Pharm.D, B.Sc. (Life Sciences), or a related qualification.
• Basic knowledge of pharmacovigilance and drug safety.
• Understanding of adverse event reporting (ICSRs) and safety documentation.
• Knowledge of MedDRA coding and ICH guidelines is an advantage.