Safety & Pharmacovigilance Specialist I – Literature Review
Updated: December 23, 2025
Location: Gurugram, Haryana, India
Job ID: 25104540
Job Type: Full-Time
Company Overview
Syneos Health® is a globally recognized, fully integrated biopharmaceutical solutions organization committed to accelerating customer success across the clinical development, medical affairs, and commercial lifecycle. Operating in over 110 countries with a workforce of more than 29,000 professionals, Syneos Health partners with leading biopharma companies to deliver therapies that improve patient lives worldwide.
With a patient-centric Clinical Development model, Syneos Health emphasizes innovation, operational excellence, regulatory compliance, and collaborative problem-solving across global teams.
Position Summary
Syneos Health is seeking a Safety & Pharmacovigilance Specialist I – Literature Review to support global drug safety and regulatory operations. This role is well-suited for professionals with prior experience in literature surveillance, ICSR processing, and safety data management within clinical trial and post-marketing environments.
The position contributes directly to regulatory compliance, patient safety, and accurate pharmacovigilance reporting across global programs.
Key Responsibilities
Conduct comprehensive literature screening and safety review to identify reportable adverse events.
Process, triage, and manage Individual Case Safety Reports (ICSRs) in alignment with SOPs, safety management plans, and global regulatory requirements.
Evaluate ICSR data for completeness, accuracy, and regulatory reportability; enter validated data into safety databases.
Perform MedDRA coding for adverse events, medical history, indications, concomitant medications, and laboratory tests.
Prepare clear, compliant, and high-quality case narratives and follow up on missing safety information until resolution.
Support expedited and routine safety reporting in compliance with applicable global regulations.
Maintain safety tracking logs and support quality review activities.
Manage duplicate case identification and reconciliation activities.
Support xEVMPD submissions, SPOR/IDMP activities, and product data maintenance.
Ensure timely and accurate filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with ICH-GCP, GVP, SOPs, Work Instructions, and global drug safety regulations.
Collaborate effectively with internal and external stakeholders and participate in audits and inspections as required.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
Minimum 2+ years of hands-on experience in pharmacovigilance literature review is mandatory.
Prior exposure to Literature Case Processing and Clinical Trial Case Processing is strongly preferred.
Experience using Drug Safety Triager databases for literature cases is advantageous.
Working knowledge of ICSR processing, MedDRA coding, drug dictionaries, and medical terminology.
Good understanding of clinical trial phases II–IV, post-marketing safety requirements, ICH-GCP, GVP, and global PV regulations.
Proficiency in Microsoft Office applications and shared document management systems.
Strong written and verbal communication skills.
Excellent organizational abilities with attention to detail and accuracy.
Ability to work independently and collaboratively within global, cross-functional teams.
Why Join Syneos Health
Contribute to programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Access structured career development, technical training, and therapeutic learning opportunities.
Work within a diverse, inclusive, and people-focused global organization.
Be part of a mission-driven team dedicated to advancing patient safety and healthcare outcomes.
Additional Information
This job description outlines primary responsibilities and may evolve based on business needs. Syneos Health is an equal opportunity employer and complies with all applicable employment, equality, and accessibility regulations. Reasonable accommodations will be provided as required.
Apply Now
Interested professionals can apply through thepharmadaily.com.
Not ready to apply? Join the Talent Network to receive updates on future Pharmacovigilance and Drug Safety opportunities globally.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Netherlands |Remote Australia :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
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Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
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Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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