Drug Safety Lead

4+ years

Not Disclosed

Bangalore

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

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 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.

If this excites you, then apply below.

Medical Reviewer / Drug Safety Lead

You will be responsible for:

Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement.
Evaluate adverse event report for seriousness, listedness/expectedness, corrects coding of the adverse event and ensures that all medically relevant information from the source documents is included, checks/corrects ranking of events, and provide causality assessment.
Confirm and rectify coding of terms in other fields such as medical history, lab details or indications.
Provide medical sign off on the case.
Ensure appropriate follow-up questions/questionnaires are sent out based on the case.
Track inconsistencies on activities performed by data entry and QC reviewer and provide feedback to QC team as learnings activities as per client requirement and agreed standards.

Your impact:

About you:

Must have:

Qualification : MBBS is mandatory
Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability.
Good comprehension skills.
Good communication and interpersonal skills.
Drive quality and ensure team meets deadlines and commitments.
Excellent mentoring and training skills.
Knowledge of disease pathology and physiology, pharmacology, and therapeutics.
Familiarity with pharmaceutical industry principles of drug development and Pharmacovigilance is preferred but not required.
Understanding of medical terminology and ability to summarize medical information
Ability to critically evaluate medical data.
Ability to accurately and medically present case data, both verbally and in writing.
Ability to identify, prioritize and assign tasks.
Consistently exercise good judgment within policies and regulations.

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, 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.