Life Sciences Drug Safety Associate Job Opening – Apply Online at Indegene
Indegene
Drug Safety Associate
Bengaluru, Karnataka, India
About the Job
We are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com.
Looking to jump-start your career?
We understand how important the first few years of your career are, as they create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth.
We are purpose-driven, enabling healthcare organizations to be future-ready. Our customer obsession is our driving force, ensuring that our customers achieve what they truly want. We are bold in our actions, nimble in our
decision-making, and industrious in the way we work.If this excites you, then apply below.
Drug Safety Associate
- Experience: A minimum of 2 years of ICSR case processing experience or its equivalent within Pharmacovigilance.
- Education: Post Graduate/Graduate degree in pharmacy, nursing, or equivalent from a life sciences background.
Responsibilities:
- Perform late case investigations and other PV compliance-related activities.
- Pull listings and perform investigations of late Individual Case Safety Reports (ICSRs) to Health Authorities (HA) and late distribution to Business Partners (BP).
- Initiate initial investigation to identify the reason for lateness and responsible organization, follow up with the responsible organization to request lateness reason and CAPA.
- Validate the information upon receipt of lateness reason and CAPA, follow up as needed, and enter the data into the compliance tool.
- Perform quality checks on the data fields in the PSR compliance dashboard to ensure data completeness and follow up with the responsible organization to resolve discrepancies.
- Perform reconciliation activities to verify the accuracy of the data configurations in client tools.
- Adhere to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards, requirements, and policies.
- Communicate and interact effectively within and across all client key stakeholders and internal team management as appropriate.
- Attend all internal and client trainings to ensure compliance with applicable guidelines.
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