Safety Physician
Location: Salem, India
Job ID: 25001289
Posted: January 30, 2025
Job Description:
Syneos Health is seeking a Safety Physician to review adverse events for investigational and marketed products and ensure regulatory compliance in pharmacovigilance. This role will involve collaboration with Safety and Pharmacovigilance (SPVG) teams, providing medical expertise in safety assessments, and reviewing aggregate safety reports.
Key Responsibilities:
Perform medical review of adverse events reported for investigational and marketed products.
Familiarize with MedDRA, WHO-DRL, and safety databases such as ARGUS.
Work closely with SPVG colleagues to ensure proper interpretation and consistency of adverse event cases.
Ensure compliance with regulatory and SOP requirements regarding safety evaluation and reporting.
Identify, communicate, and manage potential safety issues.
Provide medical review and interpretation for aggregate safety reports (e.g., PSURs, PADERs).
Maintain expertise in pharmacovigilance and clinical development through continued education.
Mentor and train internal safety staff, including case processing teams.
Perform activities in compliance with corporate and departmental policies and SOPs.
Qualifications:
Education: M.D., MBBS, or D.O.
Completed an accredited residency with at least 1-2 years of clinical practice.
Minimum of 1 year of experience in pharmacovigilance/epidemiology in 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 and language required for case processing.
Ability to travel up to 10%.
About Syneos Health:
Syneos Health is a leading biopharmaceutical solutions organization with a global presence, dedicated to accelerating customer success by addressing market challenges in clinical, medical affairs, and commercial insights.
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