Job Title: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Hyderabad, India
Job ID: 25102422
Organization: Syneos Health®
About Syneos Health
Syneos Health® is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. With operations in over 110 countries and 29,000 employees worldwide, Syneos combines clinical, medical affairs, and commercial expertise to deliver innovative solutions across the product development lifecycle.
Motto: Work Here Matters Everywhere
The company fosters a Total Self Culture—promoting authenticity, diversity, and inclusion to create a workplace where everyone feels they belong.
Position Summary
The Safety & PV Specialist II (Literature Review) is responsible for performing all aspects of Individual Case Safety Report (ICSR) collection, processing, and reporting in accordance with regulatory requirements, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and company SOPs.
The role involves conducting literature searches, extracting safety-relevant information, and ensuring compliance with global and local regulatory requirements.
Key Responsibilities
Literature Review Activities
Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant data.
Extract, summarize, and interpret key safety information from identified sources.
Design, validate, and optimize search strategies specific to pharmacovigilance purposes.
Conduct local literature searches in alignment with regional regulatory requirements.
Maintain detailed documentation of literature search strategies and outcomes.
ICSR Case Processing
Process ICSRs in compliance with SOPs and project-specific safety management plans.
Triages, evaluates, and assesses case data for completeness, accuracy, and regulatory reportability.
Enter case data into safety databases; perform medical coding for events, medical history, and medications.
Prepare detailed narrative summaries for cases.
Manage queries and follow-up communications to resolve data gaps.
Support timely and accurate reporting of expedited and periodic reports to relevant authorities.
Regulatory & Quality Compliance
Ensure adherence to GVP Module VI, ICH-GCP, and other applicable global safety regulations.
Participate in audits and inspections as required.
Ensure proper submission of all relevant documentation to the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as appropriate.
Collaborate with data management teams for safety data reconciliation.
Documentation & Support
Contribute to Safety Management Plan (SMP) preparation.
Maintain and update PVG tracking systems.
Support continuous improvement initiatives within the pharmacovigilance team.
Required Qualifications
Education: Bachelor’s degree or higher in Life Sciences, Pharmacy, Nursing, or related health profession.
Experience: Minimum 3+ years of relevant experience in Pharmacovigilance with exposure to:
Global and local literature case reviews.
Identification of NICR (Signal & AR) reports from literature.
Knowledge of GVP Module VI and literature-based surveillance processes.
Technical Skills:
Proficient with literature databases (Embase, PubMed, Medline).
Knowledge of safety database systems and medical terminology.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and TeamShare.
Core Competencies
Strong understanding of clinical trial processes (Phases II–IV) and post-marketing safety operations.
Excellent communication (written & verbal) and interpersonal skills.
Strong attention to detail and accuracy in documentation.
Effective organizational and time-management skills with the ability to handle multiple tasks.
Ability to work both independently and collaboratively in a team-oriented environment.
Willingness to travel occasionally (up to 5%).
Why Join Syneos Health
Career growth through structured training, mentorship, and cross-functional exposure.
Recognition through Total Rewards Program and peer acknowledgment.
Inclusive, diverse, and supportive work culture where authenticity is valued.
Opportunity to contribute to 94% of FDA-approved and 95% of EMA-authorized products over the past 5 years.
Additional Information
Responsibilities may evolve based on project or business needs.
Equivalent experience, education, and skills may be considered for qualification purposes.
The company is committed to equal opportunity and compliance with global labor and disability laws.
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