Job Title: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Gurugram, India
Job ID: 25102422
Organization: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine clinical, medical affairs, and commercial expertise to deliver outcomes that address real-world healthcare challenges.
With 29,000 employees in 110 countries, Syneos Health brings the patient and customer to the center of every project. Our collaborative and agile teams are driven to accelerate therapy delivery because we are passionate about improving lives.
Motto: Work Here Matters Everywhere
Why Work with Us
Strong focus on career growth and technical development through ongoing training and mentorship.
Supportive Total Self Culture promoting authenticity, diversity, and inclusion.
Peer recognition programs and total rewards structure.
A workplace that values collaboration, innovation, and individual contribution.
Position Overview
The Safety & PV Specialist II (Literature Review) performs all aspects of Individual Case Safety Report (ICSR) collection, processing, and reporting for clinical and post-marketing safety programs.
This role requires expertise in conducting systematic literature reviews, identifying safety-relevant data, and ensuring compliance with global and local pharmacovigilance (PV) regulations.
Key Responsibilities
1. Literature Review & Data Extraction
Conduct systematic and ad-hoc literature searches using global biomedical databases such as Embase, PubMed, and Medline.
Extract and summarize key safety information relevant to ICSRs and signal detection.
Develop and validate search strategies specific to pharmacovigilance objectives.
Perform local literature reviews in compliance with national regulatory requirements.
Maintain search documentation and ensure accuracy in literature data handling.
2. ICSR Case Processing
Process ICSRs in line with SOPs and project-specific Safety Management Plans (SMPs).
Triages and evaluates ICSR data for completeness, accuracy, and regulatory reportability.
Enter case data into safety databases and code events, medical history, and concomitant medications.
Write comprehensive narrative summaries and perform data quality checks.
Resolve data queries and follow-up communications for accurate case completion.
Support timely reporting of expedited and periodic reports per regulatory standards.
Coordinate with data management teams for reconciliation between clinical and safety databases.
3. Regulatory & Quality Compliance
Ensure adherence to ICH GCP, GVP Module VI, and applicable safety regulations.
Participate in audits and inspections as required.
Ensure accurate document submission to Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF).
Support the creation and maintenance of Safety Management Plans.
Maintain compliance with company SOPs, work instructions, and pharmacovigilance best practices.
Qualifications & Experience
Education
Bachelor’s or postgraduate degree in Life Sciences, Pharmacy, Nursing, or other health-related disciplines.
Equivalent education and experience combination may be considered.
Experience
Minimum 3+ years of experience in Pharmacovigilance with focus on:
Literature case review (global and local).
Identification of NICR (Signal & AR) reports from literature.
Safety data entry, coding, and case narrative development.
Mandatory: Strong knowledge of GVP Module VI and literature-based surveillance.
Technical & Professional Skills
Proficient in Embase, PubMed, Medline, and related biomedical databases.
Working knowledge of Safety Database systems and medical terminology.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and collaborative tools like TeamShare.
Strong understanding of clinical trial processes (Phases II–IV) and post-marketing safety.
Excellent written and verbal communication skills.
Strong organizational and multitasking ability with attention to detail.
Ability to work independently as well as part of a cross-functional team.
Willingness to travel occasionally (up to 5%).
About Syneos Health’s Global Impact
Partnered on 94% of all FDA-approved novel drugs and 95% of EMA-authorized products in the past five years.
Managed over 200 studies, across 73,000 sites and 675,000+ trial patients globally.
At Syneos Health, every team member contributes to advancing modern medicine in a fast-paced and evolving global environment.
Website: www.syneoshealth.com
Additional Information
Job responsibilities and requirements may be modified as per business needs.
Equivalent qualifications and relevant experience may be considered.
Syneos Health is an equal opportunity employer and complies with global disability and inclusion regulations.
Reasonable accommodations are provided under applicable laws to ensure equal employment opportunity.
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