Title:  Drug Safety Associate

Job Description

We are a technology-led healthcare solutions provider. We are 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, which 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 will 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.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure 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.

Must Have

Data Management:
•    Perform duplicate search as per the requirement.
•    Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines.
•    Identify serious adverse events, and special scenario cases which includes lack of efficacy, exposure and pregnancy case, At Risk, and product quality complaint only cases.
•    Ensure scientific rigor through accurate, complete and consistent data entry of adverse events reports from source document with emphasis on timeliness and quality.
•    Data entry of all fields including verbatim as per Client conventions.
•    Responsible for coding which includes adverse events, medical history, Lab data, Indications etc. using standardized terminology from a medical coding dictionary, such as MedDRA.
•    Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements.
•    Draft narratives summarizing the essential details of the case.
•    Identify clinically relevant information missing from case report and facilities its collection
•    Perform labeling for Serious/Non-Serious Cases
•    Request for follow-up information by using relevant questionnaire
•    Manage special requests for case processing prioritization (e.g., emails from clients regarding cases that must be processed urgently upon receipt of email notification)
•    Follow standard operating procedures (SOPs) and work instructions related to case processing. Adhere to pharmacovigilance regulations, guidelines, and internal policies to ensure compliance and data integrity. Understanding adverse event reporting requirements and compliance with data privacy regulations is important.
•    Should be open to continuous learning, staying updated with industry changes, new reporting requirements, and emerging safety concerns.

Skills:
•    Understand the principles and concepts associated with case-handling process and overall Drug Research Process.
•    Handling of cases in ArisG LSMV safety database.
•    Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking
•    Good knowledge on therapy area/medical terminology 
•    Good comprehension skills
•    Good communication (verbal and written), with fluency in English and interpersonal skills
Your impact: 
About you: (Desired profile)
Must have: 
•    Attention to detail 
•    Good comprehension skills. 
•    Good communication (verbal and written), with fluency in English and interpersonal skills. 

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.