Indegene is a healthcare solutions provider combining technology and healthcare expertise to help organizations stay future-ready. With a focus on innovation, collaboration, and customer-centric solutions, Indegene offers accelerated global growth opportunities. The company is known for nurturing talent and creating a work environment at the intersection of healthcare and technology.

Position Overview: Drug Safety Associate

Location: Bengaluru, Karnataka, India
Type: Full-time, On-site
Experience: Minimum 2 years in Individual Case Safety Reports (ICSR) case processing within pharmacovigilance.

Responsibilities:

• Perform late case investigations for pharmacovigilance (PV) compliance.
• Handle late Individual Case Safety Reports (ICSRs) to Health Authorities and business partners.
• Investigate lateness reasons, follow up with responsible organizations, and request corrective action plans (CAPA).
• Ensure data accuracy in compliance tools and perform quality checks.
• Conduct reconciliation activities to verify data configurations.
• Adhere to internal and regulatory compliance procedures.
• Participate in internal and client training sessions to stay updated on guidelines.

Qualifications:

• Postgraduate or graduate degree in pharmacy, nursing, or a related life sciences field.
• At least 2 years of experience in pharmacovigilance or ICSR case processing.

Skills:

• Proficiency in pharmacovigilance and compliance procedures.
• Strong organizational skills for managing investigations and CAPA processes.
• Attention to detail for ensuring accuracy in case reports and data fields.

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