Designation:
Drug Safety Associate
Location:
Bengaluru, Karnataka
Qualifications:
- Experience: Bring at least 2+ years of hands-on experience in Pharmacovigilance.
- Skills: Pharmacovigilance, Adverse Events, Argus Safety, Safety Case, Triage
- Expertise: Be well-versed in medical terminology and therapy areas.
- Communication: Demonstrate excellent comprehension skills and fluency in English, both written and verbal.
- Availability: Ready to jump in immediately?
Job Overview:
Join Indegene in Bengaluru as a Drug Safety Associate. In this role, you’ll check case details, search for duplicates, and follow safety rules. You’ll handle serious issues, attach documents, and follow up on cases.
We’re looking for candidates with a Pharmacy or Science background who understand medical terms and want to improve healthcare through careful case handling.
Job Role of Drug Safety Associate
- Confirm the validity of cases by identifying the minimum criteria needed for case creation, ensuring accuracy and completeness of initial reports.
- Perform thorough duplicate searches to create either initial or follow-up cases, preventing redundancy and ensuring data integrity.
- Understand and apply the principles and regulatory requirements associated with patient safety case handling, keeping up-to-date with the latest guidelines and best practices.
- Identify serious adverse events and special scenario cases, such as lack of efficacy, exposure, pregnancy cases, at-risk cases, and product quality complaints, and escalate them appropriately.
- Attach relevant source documents or any safety information to the case, maintaining meticulous records for future reference and audits.
- Facilitate follow-ups based on queries from data entry, quality control, or medical reviewers, proactively seeking additional information to ensure case completeness.
- Handle coding for adverse events, medical history, lab data, and indications using standardized medical coding dictionaries like MedDRA, ensuring consistent and accurate terminology.
- Draft detailed and coherent case narratives, providing clear and concise summaries that capture the essence of the reported events and their implications for patient safety.
- Collaborate with cross-functional teams to ensure comprehensive case evaluations and to support continuous improvement in safety reporting processes.
- Participate in training and development opportunities to enhance your knowledge and skills in pharmacovigilance and regulatory compliance.
- Contribute to the development and refinement of case handling procedures, sharing insights and best practices to improve overall efficiency and effectiveness.
Read Also: Pharmacovigilance Interview Questions PDF 2024 By Pharmajobsnow.com
What Are We Looking For?
We are looking for someone eager to start their career at the exciting intersection of healthcare and technology. You should be a quick learner who can grow with Indegene’s fast-paced global expansion.
We value bold, hardworking individuals who can make quick decisions and are focused on meeting customer needs diligently.
About Indegene:
We are a tech-focused healthcare solutions provider with a mission to help healthcare organizations be future-ready. We offer fast, global growth opportunities for those who are bold, hardworking, and quick to adapt.
At Indegene, you’ll enjoy a unique career that values entrepreneurship, passion, innovation, collaboration, and empathy. Explore exciting career opportunities at the crossroads of healthcare and technology at Indegene Careers.
Company Mission:
Indegene helps biopharma, biotech, and medical device companies develop, market, and grow their products. We combine healthcare expertise, purpose-built technology, and an agile operating model to offer a range of solutions.
Our goal is to deliver personalized, scalable, and omnichannel experiences for patients and physicians, helping healthcare organizations be future-ready.
Equal Opportunity:
Indegene is proud to be an Equal Employment Opportunity Employer. We are committed to inclusion and diversity and do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions are based on business needs, candidate merit, and qualifications.
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