Safety & PV Specialist I – Literature Review | Gurugram, India
Location: Gurugram, India
Job Type: Full-Time
Job ID: 25104540
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization focused on accelerating clinical development and commercial success. With 29,000 employees across 110 countries, we deliver innovative solutions to improve patient outcomes while streamlining processes for our clients.
We foster a diverse and inclusive work culture, supporting career growth, technical training, and recognition programs, ensuring our teams thrive both professionally and personally.
Role Overview
We are seeking a Safety & Pharmacovigilance (PV) Specialist I with expertise in literature review to support pharmacovigilance activities for clinical trials and post-marketing safety programs.
The ideal candidate will have 2+ years of experience in literature review, preferably with exposure to literature case processing and clinical trial case processing. This role is crucial in ensuring timely detection, assessment, and reporting of safety information, contributing to global patient safety.
Key Responsibilities
Pharmacovigilance & Safety Management
Enter and track Individual Case Safety Reports (ICSRs) using PVG or other safety databases.
Perform triage, assessment, coding, and narrative compilation of ICSRs.
Identify and resolve queries to ensure data completeness and regulatory compliance.
Conduct quality reviews of ICSRs and support timely submission of expedited reports.
Literature Review & Data Processing
Perform scientific literature screening and review for adverse events.
Code drugs, indications, medical history, concomitant medications, and laboratory data using MedDRA.
Maintain and update the drug dictionary, and recode unprocessed product/substance terms.
Support xEVMPD submissions, SPOR/IDMP activities, and management of duplicate ICSRs.
Compliance & Documentation
Ensure all documentation is maintained in the Trial Master File (TMF) and Pharmacovigilance System Master File according to SOPs and sponsor requirements.
Comply with ICH GCP, GVP, global regulations, and company policies for safety and clinical trial reporting.
Participate in internal/external audits and implement regulatory guidance effectively.
Collaboration & Communication
Work with cross-functional teams including clinical operations, medical, regulatory, and safety teams.
Provide input for safety signal detection, risk management assessment, and aggregate safety reports.
Communicate effectively with stakeholders, ensuring accurate, timely reporting and query resolution.
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Experience:
Minimum 2+ years of experience in literature review within pharmacovigilance.
Preferred experience in literature case processing and clinical trial case processing.
Familiarity with Drug Safety Triager or other PV databases.
Skills & Competencies:
Knowledge of clinical trial processes (Phases II–IV), post-marketing safety, and global PV regulations.
Proficient in Microsoft Office Suite, Outlook, TeamShare, and internet-based tools.
Strong communication, organizational, and analytical skills.
Ability to prioritize multiple tasks, work independently, and maintain attention to detail.
Why Join Us
Contribute to global drug safety and pharmacovigilance initiatives.
Collaborate with cross-functional teams across multiple geographies.
Access career development programs, mentorship, and training in pharmacovigilance.
Work in a culture that values diversity, inclusion, and professional growth.
About Syneos Health
Syneos Health® has partnered with 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, managing 200+ studies across 73,000 sites and over 675,000 trial patients in the last five years.
We empower employees to take initiative, challenge the status quo, and innovate in a dynamic and competitive global environment.
Apply Now
Take your career to the next level as a Safety & PV Specialist I (Literature Review) in Gurugram, India, and join a global leader in pharmacovigilance and clinical development.
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