Indegene is a technology-led healthcare solutions provider based in Bangalore, India, dedicated to enabling healthcare organizations to be future-ready. With a commitment to innovation, collaboration, and empathy, we offer accelerated growth opportunities for individuals who are bold, industrious, and agile. At Indegene, you will work at the intersection of healthcare and technology, alongside some of the brightest minds in the industry. Whether you’re just starting your career or looking to advance, you’ll find a unique environment that celebrates entrepreneurship. Explore more at Indegene Careers.
Responsibilities in Job
As a Pharmacovigilance Lead, you will play a crucial role in ensuring the safety and efficacy of products through comprehensive medical review processes. Your primary responsibilities include:
- Conducting medical reviews of Individual Case Safety Reports (ICSRs) for accuracy and medical relevance.
- Evaluating adverse event (AE) reports and ensuring all essential medical information is captured accurately.
- Providing causal assessments for serious adverse events (SAEs) using clinical methodologies conforming to global regulations.
- Reviewing case narratives and ensuring compliance with safety documents and labeling.
- Performing line listing reviews of non-serious cases and ensuring correct coding and labeling.
- Engaging in literature surveillance and performing analyses of similar events (AOSE) when required.
- Tracking and providing feedback on data entry activities to ensure adherence to quality standards.
- Contributing to pharmacovigilance and risk management planning by preparing safety surveillance strategies.
- Authoring and updating standard operating procedures (SOPs) to enhance quality and compliance.
- Presenting quality assurance data to stakeholders and attending necessary training and governance meetings.
Qualifications
To be considered for this role, candidates must possess the following qualifications:
- Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Solid understanding and proven track record in pharmacovigilance, including compliance with international regulations.
- Familiarity with the pharmaceutical industry principles, particularly drug development and pharmacovigilance, is advantageous but not mandatory.
Skills
The ideal candidate should have a mix of both hard and soft skills:
- Strong cognitive abilities, including critical thinking and analytical skills.
- Excellent verbal reasoning and attention to detail.
- Proficient comprehension skills and the ability to understand project requirements.
- Strong communication and interpersonal skills, with an ability to mentor and train others.
- Passion for driving quality in deliverables and adherence to deadlines.
- Knowledge of disease pathology, pharmacology, and therapeutics, along with experience in pharmacovigilance safety databases.
