Safety & Pharmacovigilance (PV) Coordinator – Office Based
Updated: February 6, 2026
Location: Pune, India (IND-Pune)
Job ID: 25105305
Company: Syneos Health
Experience Required: Minimum 1 Year
Job Overview
Syneos Health is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success by integrating clinical, medical affairs, and commercial expertise. The organization focuses on delivering innovative therapies by placing patients and customers at the center of its clinical development model.
As a Safety & Pharmacovigilance (PV) Coordinator, you will support pharmacovigilance operations, safety data processing, and regulatory compliance activities. This role offers an opportunity to work in a dynamic environment that promotes collaboration, innovation, and professional growth while contributing to global drug safety and patient outcomes.
Syneos Health operates across 110 countries with over 29,000 employees, providing a collaborative and performance-driven workplace that values diversity, career development, and continuous learning.
Key Responsibilities
Enter and manage data in pharmacovigilance quality and tracking systems for receipt and monitoring of Individual Case Safety Reports (ICSRs).
Process ICSRs in accordance with Standard Operating Procedures (SOPs) and project-specific safety plans.
Perform triage of ICSRs and evaluate safety data for completeness, accuracy, and regulatory reporting requirements.
Conduct data entry into safety databases, including coding of adverse events, medical history, concomitant medications, and laboratory tests.
Prepare comprehensive case narrative summaries and follow up on queries to ensure complete information.
Support timely and accurate expedited safety reporting in compliance with regulatory requirements.
Maintain safety tracking for assigned pharmacovigilance activities.
Perform literature screening and safety review, including drug coding, drug dictionary maintenance, and MedDRA coding.
Validate and submit xEVMPD product records, including appropriate MedDRA coding for indication terms.
Perform manual recoding of product and substance terms associated with ICSRs.
Identify and manage duplicate safety reports.
Support activities related to SPOR and IDMP requirements.
Conduct quality review of ICSRs and ensure compliance with safety standards.
Ensure submission of relevant documents to Trial Master File (TMF) and Pharmacovigilance System Master File as per SOPs and sponsor requirements.
Maintain compliance with global regulations, including GCP, ICH guidelines, GVP, and drug development processes.
Collaborate with internal and external stakeholders to ensure effective project execution.
Participate in audits and apply regulatory intelligence to safety reporting activities.
Eligibility Criteria and Qualifications
Education: Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) only.
Experience: Minimum 1 year of experience in post-marketing surveillance (PMS) and spontaneous case processing.
Technical Requirements:
Experience with safety databases such as LSMV or Argus (preferred).
Knowledge of safety database systems and medical terminology.
Understanding of clinical trial processes (Phase II–IV) and post-marketing safety requirements.
Familiarity with ICH GCP, GVP, and global pharmacovigilance regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, Visio, and shared workspace tools.
Core Competencies:
Strong organizational and multitasking abilities.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively in a team environment.
High attention to detail and accuracy.
Strong time management skills with the ability to meet deadlines.
Why Join Syneos Health
Syneos Health is committed to employee development through structured career progression, technical training, supportive leadership, and comprehensive rewards programs. The organization promotes an inclusive culture that values diversity, innovation, and professional growth while maintaining a strong focus on improving patient lives globally.
Over the past five years, Syneos Health has contributed to 94% of novel FDA-approved drugs, supported 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites involving more than 675,000 clinical trial participants.
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