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Associate Director/Director, Drug Safety And Pharmacovigilance Physician

7+ years
Not Disclosed
15 June 20, 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

Our client is a leading High Growth Biotech looking to expand their PV team bringing on an Associate Director/Director, Drug Safety and Pharmacovigilance Physician to serves as a critical medical and data analytical expert for the assigned investigational. The overall goal for this company is becoming the market leaders in the ADC’ s Oncology space.

 

What You’ll Do

  • Act as the SME responsible for the development of proactive risk management strategies for a portfolio of core strategic (high profile and/ or high volume and/or high complexity) investigational products within Oncology.

  • Create and implement risk management strategies for assigned

  • Analyse and produce safety evidence and perform safety & efficacy analyses to support the overall plans for the team.

  • Provide expert medical input to regulatory documents

  • Interpret clinical trial safety data for clinical trial reports and submission documents

  • Ensure patient safety while adhering to the highest quality and ethical standards

  • Represent Pharmacovigilance data to internal and external multidisciplinary committees & bodies

 

Qualifications

  • MD Required.

  • Exposure to Therapeutic Areas is preferred: Oncology

  • Extensive experience in Pharmacovigilance at a pharmaceutical company on a working on Global Clinical Trials and clinical development and post-marketing safety.

  • In-depth understanding of research methods and procedures; strong background in epidemiological theory, methods, or health informatics is a plus.

  • Excellent verbal and written communication skills.

  • Strong organizational, project management, and leadership skills.

  • Attention to detail and ability to think critically required.