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.
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