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Safety Physician

1-2 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: MD/MBBS/DO 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

Safety Physician

Location: Hyderabad, India
Job ID: 25001289
Posted: January 30, 2025

Job Description:

Syneos Health is seeking a Safety Physician to perform medical reviews of adverse events reported for investigational and marketed products. The role involves working with Safety and Pharmacovigilance (SPVG) teams, ensuring regulatory compliance, interpreting safety data, and assisting with post-marketing safety information.

Key Responsibilities:

  • Perform medical reviews of adverse events for investigational and marketed products.
  • Maintain familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.
  • Collaborate with SPVG teams for accurate medical interpretation of adverse event case assessments.
  • Ensure compliance with regulatory standards, SOPs, and safety reporting.
  • Identify and manage potential safety issues.
  • Provide medical review and interpretation for aggregate safety reports (e.g., annual safety reports, PSURs, PADERs).
  • Stay updated on clinical and drug development information.
  • Mentor and train other internal safety staff, including case processing personnel.
  • Ensure compliance with departmental policies and operating procedures.

Qualifications:

  • M.D., MBBS, D.O. required.
  • Completed an accredited residency with at least 1-2 years of clinical practice.
  • Minimum of 1 year of experience in pharmacovigilance/epidemiology within the pharmaceutical, biotechnology, or device industry.
  • Knowledge of global pharmacovigilance regulations and processes.
  • Proficiency in Microsoft Office Suite and safety databases.
  • Excellent verbal and written communication skills in English.
  • Ability to travel as necessary (up to 10%).

About Syneos Health:

Syneos Health accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. They are passionate about developing people, promoting career growth, and fostering a diverse, inclusive workplace.