✅ Senior Safety Specialist (Literature Review)
Location: Hyderabad, India
Updated: Oct 29, 2025
Job ID: 25102421
Company: Syneos Health®
About Syneos Health®
Syneos Health is a global biopharmaceutical solutions organization operating in 110+ countries with 29,000 employees, committed to accelerating clinical development. The Clinical Development model focuses on simplifying processes, collaboration, and bringing patients to the center of all decisions.
Position Overview
The Senior Safety Specialist (Literature Review) is responsible for conducting global and local literature searches, identifying reportable safety cases, processing ICSRs, ensuring regulatory compliance, and supporting PV operations across clinical and post-marketing programs.
Key Responsibilities
✅ Literature Search & Review
Conduct systematic and ad-hoc searches in Embase, PubMed, Medline and other global biomedical databases.
Extract and summarize safety-relevant information for PV use.
Develop and validate literature search strategies for global and local regulatory requirements.
Identify ICSRs, Non-Individual Case Reports (NICRs), signals, and adverse reactions from literature sources.
✅ ICSR Case Processing (as applicable)
Triage, evaluate completeness, accuracy, and regulatory reportability of ICSRs.
Enter data into safety databases; code events, history, medications, and tests.
Prepare high-quality narrative summaries.
Perform follow-up and resolve queries until information is satisfactorily obtained.
Support generation and QC of expedited regulatory reports.
Coordinate safety–clinical database reconciliations.
✅ Project Coordination & Documentation
Prepare and maintain Safety Management Plans (SMP).
Participate in internal project review meetings.
Track cases in PV quality/tracking systems.
Ensure proper submission of documents to TMF (clinical trials) and PSMF (post-marketing).
Ensure timely delivery of literature reports and ICSRs to Safety Submissions team.
✅ Compliance & Training
Maintain up-to-date knowledge of:
ICH GCP
GVP
Global/local PV regulations
Drug development process (Phases II–IV)
Provide ICSR reporting training to investigators.
Participate in audits/inspections, ensuring inspection-ready documentation.
Ensure SOP, WI, and regulatory guideline adherence.
Qualifications & Experience
✅ Education
Bachelor’s/Postgraduate degree in a health-related discipline:
– Pharmacy, Nursing, Life Sciences, or equivalent.
✅ Experience
Minimum 5 years in Pharmacovigilance with strong experience in:
Global + Local literature review
Literature case identification (ICSR/NICR)
QC review, citations, and workflow oversight
Experience in mentoring, training, work allocation, and quality checks.
✅ Technical Skills
Strong understanding of:
Medical terminology
Literature review processes
Safety databases
ICH GCP, GVP, global PV regulations
Proficiency in Microsoft Office (Word, Excel, PPT), Visio, Outlook, shared content platforms.
✅ Soft Skills
Excellent communication skills
Strong organization and multi-tasking ability
Detail-oriented with high accuracy
Ability to work independently and collaboratively
Effective decision-making ability
Minimal travel required (up to 10%)
Additional Notes
Syneos may assign additional duties as needed. Equivalent combinations of education/experience may be considered. The company maintains compliance with global employment laws and disability accommodation requirements.
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Siliguri |Illinois :
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Bangor | Brewer |New Jersey :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
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Argentina | Peru |Brazil :
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Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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New Mexico | Ciudad de México |Dubai :
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Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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