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Senior Drug Safety Physician

2+ years
Not Disclosed
10 Oct. 30, 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, 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 Purpose:

The Medical Review Specialist provides critical medical review, analysis, and guidance throughout the case handling and reporting cycle of Adverse Event and Adverse Reaction reports for investigational and marketed products. This role involves collaborating with Drug Safety Associates (DSAs) and other specialists to ensure the highest standards of drug safety.

General Responsibilities:

  • Maintain a comprehensive understanding of the adverse event profiles of assigned products, including labeling documents and data handling conventions.
  • Stay informed about global regulatory requirements and manage workloads to ensure compliance with internal and regulatory timelines for adverse event reporting.
  • Communicate and resolve issues related to the review process with the Project Manager and relevant stakeholders.
  • Participate in client and cross-functional meetings, providing expert input as a Subject Matter Expert (SME).
  • Assist in inspection readiness activities and audits, contributing to process improvements and coordination to meet key performance indicators (KPIs).

Case Report Medical Review:

  • Conduct medical reviews of cases in accordance with client Standard Operating Procedures (SOPs).
  • Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess causality for reported events.
  • Evaluate the seriousness and expectedness of adverse events and provide medical advice to Drug Safety Personnel (DSPs) and case processing teams.
  • Perform literature reviews to support product safety assessments and identify potential safety issues.

Skills:

  • Excellent interpersonal, verbal, and written communication abilities.
  • Proficient with web-based applications and the Windows operating system.
  • Client-focused with a flexible approach to work assignments and learning opportunities.
  • Strong ability to manage multiple tasks with attention to detail and enthusiasm.
  • Ability to assess the clinical relevance of medical data and interpret its implications effectively.
  • Willingness to work collaboratively in a matrix environment, valuing teamwork.

Knowledge and Experience:

  • A minimum of 2 years of relevant experience in Pharmacovigilance or drug safety is desirable.

Education:

  • MBBS or a Postgraduate degree in Medicine, complemented by relevant experience.

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