Position: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Hyderabad, India
Job ID: 25102422
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our mission is to bring patients and customers to the center of everything we do — simplifying processes and innovating to improve the delivery of life-changing therapies worldwide.
With more than 29,000 employees in 110 countries, we collaborate to transform healthcare with passion, integrity, and agility.
Motto: Work Here Matters Everywhere.
Why Join Us
Career development and continuous learning opportunities
Supportive, engaged, and inclusive culture
“Total Self” philosophy — encouraging authenticity and diversity
Recognition programs and competitive total rewards
Global exposure and contribution to meaningful projects
Key Responsibilities
Conduct systematic and ad-hoc literature searches in biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant data.
Extract and summarize key safety information from literature sources.
Create and validate literature search strategies for pharmacovigilance purposes.
Manage local literature searches and reviews per regulatory requirements.
Enter and track ICSR information in PVG systems.
Process ICSRs as per SOPs and project-specific safety plans:
Triaging and evaluating data for completeness, accuracy, and reportability
Data entry and medical coding (events, history, medications, tests)
Narrative writing and follow-up on queries
Supporting expedited reporting and data reconciliation
Support preparation of Safety Management Plans.
Coordinate with Safety Submissions teams for distribution of reports.
Participate in audits and inspections.
Maintain documentation in Trial Master File (TMF) and PV System Master File (PSMF) as per guidelines.
Ensure compliance with SOPs, GCP, ICH, GVP, and applicable regulations.
Qualifications
Bachelor’s Degree in Life Sciences, Pharmacy, Nursing, or related discipline.
Minimum 3+ years of experience in Pharmacovigilance, particularly in Literature Case Review (Global + Local).
Proficiency in identifying NICR, Signal, and Aggregate Reports from literature.
Strong knowledge of GVP Module VI, ICH GCP, and global PV regulations.
Expertise in major databases: Embase, PubMed, Medline.
Familiarity with Safety Database systems and medical terminology.
Excellent written and verbal communication skills.
Advanced proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and collaborative tools (e.g., TeamShare, Visio).
Strong organizational skills, accuracy, and attention to detail.
Ability to work independently and within cross-functional teams.
Minimal travel (up to 5%).
Preferred Attributes
Postgraduate qualification in Health Sciences or Pharmacy.
Demonstrated ability to prioritize multiple projects under tight deadlines.
Proven understanding of clinical trial phases (II–IV) and post-marketing safety requirements.
About Syneos Health – Quick Facts
Partnered in 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the last 5 years.
Supported 200+ studies, 73,000+ sites, and 675,000+ trial patients globally.
Committed to diversity, inclusion, and innovation.
Application Link
Apply Now on Syneos Health Careers
Note
This job description outlines core duties and qualifications but may not be exhaustive. Equivalent skills and experiences will be considered. Syneos Health complies with all applicable employment and equality laws, including reasonable accommodations under the Americans with Disabilities Act.
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