Job Title: Safety & PV Specialist I – Literature Review
Category: Pharmacovigilance / Drug Safety
Location: Pune, India
Employment Type: Full-Time
Job ID: 25104540
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating therapy development and improving patient outcomes globally. With a presence in 110 countries and a workforce of 29,000+ employees, we deliver innovative clinical development, medical affairs, and commercial solutions that address the world’s most complex healthcare challenges.
Our Clinical Development model places patients and clients at the center, promoting efficiency, innovation, and compliance in clinical trials. We foster an inclusive, collaborative culture where diverse perspectives and expertise are valued.
The Safety & PV Specialist I – Literature Review will support pharmacovigilance (PV) operations through literature surveillance, case processing, and safety database management. This role contributes to regulatory-compliant safety reporting, ensuring timely detection of adverse events and maintaining high-quality safety data for clinical trials and post-marketing programs.
Enter and track Individual Case Safety Reports (ICSRs) in PV quality systems according to SOPs and project-specific safety plans.
Perform literature screening and review for adverse events, drug coding, and maintenance of the MedDRA dictionary.
Conduct validation and submission of xEVMPD product records, including MedDRA coding of indication terms.
Identify, manage, and resolve duplicate ICSRs and recode unprocessed product or substance terms.
Perform quality review of ICSRs and ensure all documentation is submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File as appropriate.
Ensure compliance with GCP, ICH, GVP guidelines, SOPs, work instructions, and global regulatory requirements.
Collaborate with cross-functional teams, including clinical, regulatory, and medical safety teams.
Participate in audits and contribute to continuous process improvement initiatives.
Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or equivalent combination of education and experience.
Experience: Minimum 2+ years in literature review; candidates with additional experience in literature case processing and clinical trial case processing are preferred.
Technical Skills: Familiarity with safety databases (e.g., PVG) and medical terminology; knowledge of MedDRA coding and SPOR/IDMP activities.
Strong understanding of clinical trial phases II–IV, post-marketing safety requirements, and pharmacovigilance regulations.
Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and collaboration tools like Team Share.
Excellent communication, interpersonal, and organizational skills with the ability to prioritize multiple tasks.
Detail-oriented with a high degree of accuracy and ability to meet deadlines independently and within a team.
Work on global clinical trials and post-marketing programs, contributing to patient safety and regulatory compliance.
Gain exposure to advanced pharmacovigilance workflows, literature case processing, and safety signal detection.
Develop expertise in MedDRA coding, xEVMPD submissions, and safety database management.
Collaborate within an inclusive, diverse, and globally connected team that values innovation, professional growth, and continuous learning.
Equal Opportunity Employer: Syneos Health is committed to diversity, equity, and inclusion. Candidates with transferable skills are encouraged to apply. Reasonable accommodations are available for individuals with disabilities during the recruitment process.
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Zagreb |Estonia :
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Kyiv |Lima Region :
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