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Safety Physician

Syneos Health
Syneos Health
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: Pune, India
Job ID: 25001289
Posted: January 30, 2025

Job Description:

Syneos Health is seeking a Safety Physician to perform medical reviews of adverse events related to investigational and marketed products, ensuring regulatory compliance in safety evaluations. The position involves collaborating with Safety and Pharmacovigilance (SPVG) teams to manage safety issues, interpret adverse event cases, and support the development of aggregate safety reports.

Key Responsibilities:

  • Review adverse events for investigational and marketed products.
  • Maintain knowledge of MedDRA, WHO-DRL, and safety databases such as ARGUS.
  • Collaborate with SPVG colleagues to ensure proper medical interpretation of adverse event cases.
  • Ensure compliance with regulatory and SOP requirements regarding safety evaluations and reporting.
  • Identify and manage potential safety issues.
  • Provide medical review for aggregate safety reports (e.g., annual safety reports, PSURs).
  • Mentor and train internal safety staff, including case processing teams.
  • Stay updated on clinical and drug development information related to contracted programs.
  • Comply with Corporate and Departmental Policies and SOPs.

Qualifications:

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

About Syneos Health:

Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. With 29,000 employees in over 110 countries, Syneos Health offers a dynamic environment where employees contribute to shaping the future of biopharmaceuticals and healthcare.