Location: Pune, India
Company: Syneos Health
Job ID: 25105747
Experience Required: 1–3 years (Not suitable for freshers)
About the Company
Syneos Health is a globally established, fully integrated biopharmaceutical services organization focused on accelerating clinical development and commercialization. With a strong presence across global markets, the organization collaborates with leading pharmaceutical innovators to deliver high-impact healthcare solutions.
Job Overview
The Safety Physician is a critical role within the Pharmacovigilance and Drug Safety function, responsible for medical evaluation of adverse events across clinical and post-marketing settings. This position demands strong clinical judgment, regulatory awareness, and expertise in safety data interpretation to ensure patient safety and compliance with global pharmacovigilance standards.
Key Responsibilities
Perform comprehensive medical review and assessment of adverse events for investigational and marketed products
Apply medical judgment to ensure accurate causality assessment, case evaluation, and safety signal identification
Work closely with Pharmacovigilance (PV) and Drug Safety teams to maintain consistency in medical evaluation
Ensure compliance with global regulatory requirements, ICH guidelines, and internal SOPs
Utilize safety databases such as ARGUS and coding dictionaries including MedDRA and WHO-DRL
Identify and escalate potential safety concerns or emerging risk signals
Contribute to aggregate safety reports including PSURs, PADERs, and annual safety reports
Collaborate with internal stakeholders and client medical teams for safety discussions and clarifications
Stay updated with ongoing clinical development programs, therapeutic areas, and regulatory changes
Mentor and support junior safety staff and case processing teams
Participate in training, audits, and continuous medical education activities
Required Qualifications
MBBS degree (Mandatory); MCI/NMC registration required if degree obtained internationally
Completion of accredited medical residency preferred
1–2 years of clinical practice experience preferred
Minimum 1 year of experience in Pharmacovigilance or Drug Safety is mandatory
Strong knowledge of global pharmacovigilance regulations and safety reporting requirements
Hands-on experience with safety databases (e.g., ARGUS) and coding systems (MedDRA, WHO-DRL)
Proficiency in Microsoft Office tools and clinical data systems
Excellent written and verbal communication skills in English
Strong analytical, decision-making, and stakeholder management abilities
Willingness to travel up to 10% if required
Why This Role Matters
Direct involvement in ensuring drug safety and patient protection on a global scale
Opportunity to work on both clinical trial and post-marketing safety data
Exposure to international regulatory frameworks and aggregate reporting
Career growth within pharmacovigilance, risk management, and medical review domains
Important Note for Applicants
This role requires prior experience in pharmacovigilance along with a medical background. Freshers are not eligible for this position. Candidates without PV experience may consider entry-level roles such as Drug Safety Associate or Medical Reviewer trainee positions before progressing to Safety Physician roles.
How to Apply
Apply through the official careers page of the company or explore verified global pharmacovigilance jobs on ThePharmaDaily.com
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