Clinical Project Assistant
SanofiÂ
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Job Description
Location: Gurgaon, Haryana, India
Job Type: Full-time (On-site)
Organization: Syneos Health
Experience Level: Entry to Intermediate (Pharmacovigilance / Safety Operations)
Introduction
Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist I to join its global clinical development team. In this role, you will be responsible for ensuring the collection, processing, and reporting of safety information in compliance with global regulatory requirements and company procedures.
This position offers the opportunity to work with one of the world’s most trusted biopharmaceutical partners, contributing directly to the safe and effective delivery of new therapies to patients worldwide.
Role & Responsibilities
- Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) to identify ICSRs and safety-relevant information.
- Extract, summarize, and validate key safety data from literature sources for regulatory reporting.
- Develop and validate search strategies aligned with pharmacovigilance requirements.
- Perform local and global literature reviews in compliance with regulatory guidelines.
- Enter safety information into PVG tracking systems for ICSR receipt, evaluation, and follow-up.
- Process ICSRs according to SOPs, project-specific safety plans, and regulatory timelines.
- Evaluate ICSR data for completeness, accuracy, and reportability.
- Perform MedDRA coding for events, medical history, and concomitant medications.
- Compile narrative summaries and follow up on missing or unclear safety information.
- Assist in the generation and submission of expedited safety reports to health authorities.
- Maintain safety tracking logs and quality documentation for all PV activities.
- Conduct validation and submission of xEVMPD product records and manage SPOR/IDMP-related activities.
- Support duplicate case management, literature screening, and drug dictionary maintenance.
- Perform quality review of ICSRs to ensure accuracy and regulatory compliance.
- Ensure all relevant safety documents are archived in the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as applicable.
- Stay compliant with GCP, ICH guidelines, GVP, and internal SOPs.
- Foster collaborative relationships with project teams and external stakeholders.
- Participate in audits and apply regulatory intelligence to daily safety operations.
Educational Qualification
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline.
- Equivalent education or experience may be considered.
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Experience & Skills - Strong understanding of pharmacovigilance processes, clinical trial phases II–IV, and post-marketing safety requirements.
- Familiarity with safety databases, xEVMPD, and MedDRA coding.
- Knowledge of regulatory frameworks (ICH-GCP, GVP, FDA, EMA).
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and document-sharing tools.
- Excellent communication and interpersonal skills.
- Strong organizational skills and attention to detail with the ability to handle multiple tasks.
- Ability to work independently and collaboratively in a global team environment.
Location
 Gurgaon, Haryana, India
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