Safety & Pharmacovigilance Specialist II – Literature or Clinical Trial Case Processing
Company: Syneos Health®
Job ID: 25104809-OTHLOC-5448
Location: Gurugram / Hyderabad, India
Employment Type: Full-Time
Experience Required: Minimum 3.5 years
Updated On: January 20, 2026
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success and improving patient outcomes. With integrated expertise across clinical development, medical affairs, and commercial solutions, Syneos Health supports innovative therapies worldwide. Operating across more than 110 countries with a workforce of over 29,000 professionals, the organization is committed to operational excellence, innovation, and a people-centric culture.
Job Overview
Syneos Health is seeking a Safety & Pharmacovigilance Specialist II with strong expertise in Literature Case Processing or Clinical Trial Case Processing. The role involves end-to-end Individual Case Safety Report (ICSR) processing, regulatory compliance, literature surveillance, and safety data management across clinical trial and post-marketing environments. This position plays a critical role in ensuring patient safety and regulatory compliance throughout the drug development lifecycle.
Key Responsibilities
Perform end-to-end processing of Individual Case Safety Reports (ICSRs) in accordance with SOPs, Work Instructions, and project-specific safety plans
Triage and evaluate ICSRs for completeness, accuracy, seriousness, expectedness, and regulatory reportability
Enter and maintain safety data within validated pharmacovigilance databases
Code adverse events, medical history, laboratory tests, and concomitant medications using MedDRA and WHO Drug dictionaries
Prepare high-quality case narratives and perform follow-up activities to obtain missing or clarifying information
Support the generation, validation, and submission of expedited and regulatory safety reports within defined timelines
Conduct literature screening and safety review for adverse event identification
Perform xEVMPD product record validation and submission, including MedDRA indication coding
Identify and manage duplicate cases and perform manual recoding activities as required
Support SPOR / IDMP-related pharmacovigilance activities
Perform quality review of ICSRs to ensure data integrity and compliance
Ensure timely filing of safety documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF)
Maintain compliance with global pharmacovigilance regulations, including ICH GCP, GVP, and applicable regional requirements
Participate in audits, inspections, and regulatory intelligence implementation
Collaborate effectively with cross-functional, internal, and external stakeholders
Required Qualifications
Education: B.Pharm / M.Pharm / PharmD / BDS
Experience: Minimum 3.5 years of hands-on experience in Pharmacovigilance
Mandatory experience in Clinical Trial Case Processing or Literature Case Processing
Strong working knowledge of pharmacovigilance processes and global safety regulations
Experience with safety database systems and medical terminology
Sound understanding of clinical trial phases II–IV and/or post-marketing safety requirements
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint), Outlook, and document management tools
Excellent written and verbal communication skills
Strong organizational skills with the ability to manage multiple priorities and meet strict deadlines
High attention to detail with a strong commitment to data accuracy and quality
Why Join Syneos Health
Work with a global leader involved in the majority of FDA-approved and EMA-authorized products
Access continuous professional development, technical training, and career progression opportunities
Be part of a diverse, inclusive, and collaborative work culture
Contribute directly to patient safety and public health on a global scale
Additional Information
This job description outlines the primary responsibilities of the role but is not exhaustive. Syneos Health reserves the right to assign additional duties as required. Equivalent combinations of education, experience, and skills may be considered. Employment terms comply with all applicable local and international employment regulations.
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Renfrew | Australia | North York | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
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 :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Tel Aviv | Yavne |Remote :
Xzagreb | Thailand | Switzerland | Remote | Remote, USA | Hungary | Minnesota | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Ireland | French | Manipal | Medan | Melbourne | Springville | Zaragoza | Castlebar | Texas | McFarland | Bishop | Lousiana | Belgium | Green Way | Riga | Victoria | Slovakia | Bountiful | Lenexa | Remote - Africa | Remote - Europe | Faridabad | Blue Bell | Hammond | Remote - Middle East | Remote - South America (Latin Americal) | Tulsa | Leinster |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Khulais | Rabigh | Najran | King Abdullah Economic City | Jeddah | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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