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.
