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Senior Drug Safety Physician

2+ years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Remote Education: MBBS/Post Graduation in Medicine Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

 

Job Title: Senior Drug Safety Physician

Location: India (Remote)
Additional Locations: Hyderabad, India (Remote)
Job ID: R0000027679
Department: Medical Sciences
Company: Parexel


Job Purpose

  • Provide medical review, analysis, and guidance throughout the adverse event (AE) and adverse drug reaction (ADR) case handling and reporting cycle for investigational and marketed products.

  • Offer medical support to Drug Safety Associates (DSAs) and contribute to medical aspects of drug safety.

  • Contribute medical content to narratives written for Clinical Study Reports (CSRs).


Key Responsibilities

General

  • Maintain updated knowledge of AE profiles, labeling documents, conventions, client guidelines, and international regulations.

  • Ensure compliance with global regulatory requirements and timelines.

  • Participate in client and cross-functional meetings.

  • Train and mentor new team members; act as a Subject Matter Expert (SME).

  • Assist in inspection readiness and audit activities.

  • Support process coordination to meet Key Performance Indicators (KPIs).

Case Report Medical Review

  • Conduct medical review of safety cases as per client SOPs.

  • Write Pharmacovigilance/MAH comments and assess causality.

  • Determine seriousness and expectedness of events.

  • Provide medical advice to the drug safety processing team.

Literature Review

  • Perform literature review for product safety assessments and potential safety issues (as applicable).


Skills Required

  • Strong interpersonal, verbal, and written communication skills

  • Computer literacy and ability to work with web-based applications

  • Client-focused, adaptable, and eager to learn

  • Multitasking ability with high attention to detail

  • Analytical skills to assess the clinical relevance of medical data

  • Familiarity with international drug regulations (GCP, GVP)

  • Ability to work in a matrix and team-oriented environment


Knowledge and Experience

  • Minimum 2 years of relevant experience in Pharmacovigilance or Drug Safety preferred


Educational Qualification

  • MBBS or Postgraduate degree in Medicine with relevant pharmacovigilance experience