Pharmacovigilance Associate

Role & responsibilities

• Perform Individual Case Safety Report (ICSR) processing, including case intake, data entry, validation, and follow-up.
• Review and assess adverse event reports from clinical trials, spontaneous sources, literature, and other safety databases.
• Perform case coding using MedDRA and WHO Drug/appropriate coding dictionaries.
• Conduct seriousness, expectedness, and causality assessments as per applicable procedures and guidelines.
• Prepare and submit safety reports within defined regulatory timelines.
• Perform duplicate checks, quality review, and data reconciliation to ensure accuracy and completeness.
• Support follow-up activities for missing or incomplete safety information.
• Maintain accurate documentation and comply with SOPs, GVP guidelines, and regulatory requirements.
• Assist with aggregate safety reporting, signal detection, and safety data analysis as required.
• Collaborate with Clinical, Regulatory Affairs, Medical Writing, and other cross-functional teams.
• Ensure compliance with applicable global pharmacovigilance regulations and company quality standards.

Preferred candidate profile

• Bachelors or Masters degree in Pharmacy, Life Sciences, Medicine, Biotechnology, Nursing, or a related field.
• 03 years of experience in Pharmacovigilance/Drug Safety is preferred; freshers with relevant PV training may also be considered.
• Good understanding of Pharmacovigilance principles, ICSR processing, adverse event reporting, and safety databases.
• Knowledge of MedDRA coding and case processing workflows is an advantage.
• Familiarity with GVP guidelines, ICH guidelines, and regulatory reporting requirements.
• Experience or training in Argus Safety, Medidata Rave, or other pharmacovigilance databases is preferred.
• Strong attention to detail and ability to work accurately with safety data.
• Good written and verbal communication skills.
• Ability to manage multiple cases and meet strict regulatory timelines.
• Good analytical, documentation, and problem-solving skills.
• Willingness to work in a team-oriented and process-driven environment.

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