Principal Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Updated: Yesterday
Location: Gurgaon, Haryana, India (Office-based: Gurugram/Hyderabad)
Job ID: 25104927
Employment Type: Full-Time
About Syneos Health®
Syneos Health® is a leading global biopharmaceutical solutions organization, uniquely positioned to accelerate customer success. By integrating clinical development, medical affairs, and commercial capabilities, Syneos Health delivers innovative solutions that address the evolving demands of the global healthcare market.
With operations across more than 110 countries and a workforce of over 29,000 professionals, Syneos Health places patients and customers at the center of everything it does. The organization fosters agility, collaboration, and operational excellence to bring life-changing therapies to patients worldwide.
Position Overview
Syneos Health is seeking an experienced Principal Safety & Pharmacovigilance Specialist – Literature Case Processing & Review to support global and local pharmacovigilance activities. This role is responsible for end-to-end literature surveillance, Individual Case Safety Report (ICSR) processing, safety trend analysis, and regulatory compliance across clinical trial and post-marketing programs.
The position requires strong subject matter expertise in literature review, safety databases, global PV regulations, and team leadership.
Key Responsibilities
Literature Surveillance & Safety Review
Conduct systematic and ad-hoc literature searches using global biomedical databases such as Embase, PubMed, and Medline for safety signal and ICSR identification.
Develop, validate, and optimize literature search strategies in alignment with global pharmacovigilance requirements.
Extract, analyze, and summarize safety-relevant data from published literature.
Perform local and global literature reviews in compliance with regulatory expectations.
Pharmacovigilance Operations
Process ICSRs in accordance with SOPs and project-specific safety plans.
Perform ICSR triage, assess data completeness, accuracy, and regulatory reportability.
Enter, code, and validate safety data in safety databases, including medical history, adverse events, concomitant medications, and tests.
Prepare high-quality narrative case summaries and follow up on safety queries to resolution.
Support expedited and periodic safety reporting in compliance with global regulatory timelines.
Coordinate safety data reconciliation with clinical and data management teams.
Program & Process Management
Prepare and maintain Safety Management Plans (SMPs).
Manage work allocation, reporting timelines, and program deliverables in line with program management plans.
Ensure process implementation, compliance, and continuous quality improvement.
Generate accurate, error-free reports and outputs for internal and external stakeholders.
Support safety trend analysis and provide standardized data for management reporting.
Leadership & Compliance
Act as a subject matter expert (SME) for literature case processing and pharmacovigilance activities.
Mentor and support team members in day-to-day operational and troubleshooting activities.
Provide training to investigators on ICSR reporting requirements.
Participate in audits, inspections, and internal review meetings.
Ensure timely filing of safety documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain inspection readiness and compliance with SOPs, WIs, ICH GCP, GVP, and global regulatory requirements.
Support business development activities, including proposal input and bid defense meetings, as required.
Required Qualifications & Experience
Education: B.Pharm, M.Pharm, PharmD, BDS, or BMS (Life Sciences background preferred)
Experience:
Minimum 8 years of hands-on experience in pharmacovigilance with a strong focus on literature case processing and review
Prior team leadership or supervisory experience is mandatory
In-depth knowledge of global and local pharmacovigilance regulations, including ICH GCP, GVP, and post-marketing safety requirements
Strong understanding of clinical trial processes across Phases II–IV and post-marketing surveillance
Proficiency in safety database systems and medical terminology
Advanced working knowledge of Microsoft Office Suite (Word, Excel, PowerPoint), email systems, and document management tools
Excellent written and verbal communication, presentation, and interpersonal skills
Strong organizational and time-management abilities with attention to detail
Ability to work independently and manage multiple projects in a fast-paced environment
Strong decision-making and problem-solving skills
Additional Information
Work Location: Office-based role (Gurugram or Hyderabad)
Travel Requirement: Minimal travel (up to 10%)
Tasks and responsibilities may evolve based on business and project requirements.
Equivalent combinations of education, training, and experience will be considered.
Why Join Syneos Health?
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and over 675,000 trial participants
At Syneos Health, professionals are empowered to challenge conventions, innovate collaboratively, and contribute to meaningful global healthcare outcomes.
Explore global opportunities in Pharmacovigilance, Drug Safety, and Clinical Research with Syneos Health on ThePharmaDaily.com
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