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Safety Physician - Icsr

1-2 years
Not Disclosed
10 July 9, 2025
Job Description
Job Type: Remote Education: M.D., MBBS, or D.O. degree 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 – ICSR (Remote, India) at Syneos Health

Location: Remote – India
Employment Type: Full-time
Salary Range: Competitive (based on experience)
Work Hours: Standard business hours (with flexibility)
Company: Syneos Health
Posted Date: June 13, 2025


Job Summary:

Syneos Health is seeking an experienced Safety Physician specializing in Individual Case Safety Report (ICSR) review to join its global pharmacovigilance team. In this remote position, you will provide expert medical review of adverse event reports, lead safety surveillance activities, and collaborate cross-functionally to ensure patient safety and regulatory compliance. This role is ideal for MDs or equivalent with clinical and pharmacovigilance experience looking to work with one of the world’s leading biopharmaceutical solutions companies.


Key Responsibilities:

  • Perform medical review of ICSRs for investigational and marketed products

  • Ensure consistency and medical accuracy in safety case evaluations

  • Collaborate with pharmacovigilance and medical teams on safety strategy

  • Evaluate clinical safety data for signals, trends, and potential risks

  • Contribute to the preparation of aggregate safety reports (PADERs, PSURs, DSURs)

  • Stay updated on drug development and relevant therapeutic areas

  • Mentor case processors and junior medical reviewers as needed

  • Ensure compliance with global PV regulations, SOPs, and industry standards

  • Utilize MedDRA coding, WHO Drug Dictionary, ARGUS, and other safety systems

  • Participate in client meetings and provide medical expertise in regulatory interactions


Required Skills & Qualifications:

  • M.D., MBBS, or D.O. degree (mandatory)

  • Completion of an accredited residency program

  • Minimum 1–2 years of clinical practice experience

  • At least 1 year of pharmacovigilance experience preferred

  • Proficiency in MedDRA, ARGUS or similar PV systems

  • Knowledge of global PV regulations (FDA, EMA, ICH-GCP, GVP)

  • Strong written and verbal communication skills in English

  • Proficient in Microsoft Office (Word, Excel, PowerPoint), TeamShare, and other collaborative tools

  • Ability to work independently and collaborate across global teams

  • Willingness to travel occasionally (up to 10%)


Perks & Benefits:

  • Work-from-home flexibility (Remote – India)

  • Career development and internal mobility opportunities

  • Exposure to global drug safety operations and cross-functional collaboration

  • Competitive compensation package and performance incentives

  • Employee recognition programs and continuous education

  • Diverse, inclusive, and globally connected work culture


About Syneos Health:

Syneos Health is a fully integrated, global biopharmaceutical solutions organization known for accelerating clinical development, medical affairs, and commercialization. With over 29,000 employees across 110 countries, we’ve supported 94% of novel FDA drug approvals in the last five years. We are driven by passion, collaboration, and a commitment to patient-centered healthcare solutions.


Work Mode: Remote (India-based)


Call to Action:

Ready to take your pharmacovigilance career to the next level with a global leader in drug safety? Apply now to join Syneos Health as a Safety Physician – ICSR and make a global impact in patient safety and regulatory compliance.