Safety Physician – ICSR | Drug Safety & Pharmacovigilance | Pune
Job Summary:
Syneos Health is seeking a highly skilled Safety Physician – ICSR for its Pune location. The ideal candidate will be responsible for the medical review of adverse events (AEs) and serious adverse events (SAEs) reported during clinical trials and post-marketing surveillance. This role is perfect for a qualified physician (MBBS/MD) with experience in pharmacovigilance and safety databases such as ARGUS, along with strong knowledge of global regulatory requirements including MedDRA and WHO-DRL.
Join a global biopharmaceutical powerhouse that partners on 94% of all FDA-approved novel drugs and is driven to deliver patient-focused solutions worldwide.
Key Responsibilities:
Perform medical review and evaluation of individual case safety reports (ICSRs)
Ensure consistency and accuracy in adverse event assessments and safety data interpretation
Collaborate with pharmacovigilance teams to manage safety concerns and ensure regulatory compliance
Engage with client safety and medical personnel regarding safety-related issues
Interpret and medically review aggregate reports (e.g., PSURs, PADERs, annual reports)
Maintain up-to-date knowledge of therapeutic areas, drug development, and safety regulations
Mentor and guide case processing staff and junior team members
Ensure SOP and global regulatory compliance in all activities
Support audit readiness and inspections
Participate in internal and external training initiatives and CME
Required Skills & Qualifications:
Medical degree (MD, MBBS, DO); completed accredited residency preferred
1–2 years of clinical practice and minimum 1 year of experience in pharmacovigilance
Knowledge of MedDRA, WHO-DRL, and ARGUS or similar safety databases
Familiarity with global PV regulations (e.g., FDA, EMA, ICH-GCP)
Proficiency in Microsoft Office and pharmacovigilance software
Excellent communication and interpersonal skills
Ability to work cross-functionally and manage safety data independently
Fluent in English (written and spoken)
Willingness to travel occasionally (up to 10%)
Perks & Benefits:
Career growth opportunities in a global pharmaceutical environment
Structured training and certification support
Inclusive and diverse work culture
Work with a leading CRO managing top pharmaceutical and biotech clients
Employee wellness and recognition programs
Competitive compensation and potential for global mobility
Company Description:
Syneos Health is a global, fully integrated biopharmaceutical solutions provider with 29,000 professionals operating in over 110 countries. We bring together clinical development, medical affairs, and commercial strategy to accelerate the delivery of innovative therapies, supporting over 94% of all novel FDA drug approvals in recent years.
Work Mode:
On-site – Pune, India
Call to Action:
Advance your career in pharmacovigilance and drug safety. Apply now for the Safety Physician – ICSR role at Syneos Health and play a critical role in ensuring patient safety across global drug development programs.
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