Senior Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Job Requisition ID: 25104484
Employment Type: Full-Time | Hybrid
Locations: Gurugram, Haryana | Hyderabad, Telangana
Experience Required: Minimum 5 years
Industry: Pharmacovigilance | Drug Safety | Clinical Research
About the Company
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into measurable outcomes. With a presence in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health supports the development of innovative therapies that improve patient lives worldwide.
Job Overview
Syneos Health is seeking a Senior Safety & Pharmacovigilance Specialist with strong expertise in literature case processing and review. This role is critical in identifying, evaluating, and processing Individual Case Safety Reports (ICSRs) from global and local scientific literature, ensuring compliance with international pharmacovigilance regulations.
The position is office-based in Gurugram or Hyderabad with a hybrid working model.
Key Responsibilities
Conduct systematic and ad-hoc literature searches in global biomedical databases such as Embase, PubMed, and MEDLINE to identify safety-relevant information and ICSRs
Design, execute, and validate literature search strategies for pharmacovigilance purposes
Extract, assess, and summarize critical safety data from scientific publications
Perform local and global literature surveillance in compliance with regulatory requirements
Coordinate workflows to ensure timely and high-quality project delivery
Prepare and maintain Safety Management Plans
Participate in internal project review and safety governance meetings
Process ICSRs in accordance with SOPs and project-specific safety plans, including:
Case triage and assessment for completeness, accuracy, and reportability
Data entry and coding (MedDRA, WHO-DD) in safety databases
Narrative writing and medical review
Query management and follow-up with stakeholders
Support the preparation and submission of expedited and periodic safety reports
Collaborate with data management teams to reconcile clinical and safety databases
Ensure accurate and timely filing of documents in TMF and PV System Master File
Provide training to investigators on ICSR reporting requirements
Act as a Subject Matter Expert (SME), supporting team members and resolving operational issues
Participate in audits and regulatory inspections as required
Contribute to safety trend analysis and continuous process improvement initiatives
Required Qualifications & Experience
Educational Qualification:
B.Pharm, M.Pharm, PharmD, BDS, or BMS
Experience:
Minimum 5 years of hands-on experience in literature case processing within pharmacovigilance
Prior SME-level experience in safety literature review is mandatory
Strong understanding of:
Global and local pharmacovigilance regulations
ICH GCP, GVP guidelines, and drug safety reporting requirements
Clinical trial phases (II–IV) and post-marketing safety surveillance
Experience working with safety databases and medical terminology
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and collaboration tools
Key Skills & Competencies
Advanced literature search and analytical skills
Strong attention to detail with a high level of accuracy
Excellent written and verbal communication skills
Ability to manage multiple priorities in a fast-paced environment
Strong problem-solving and decision-making capabilities
Ability to work independently as well as collaboratively within cross-functional teams
Additional Information
Minimal travel may be required (up to 10%)
Hybrid work model with office presence in Gurugram or Hyderabad
Why Join Syneos Health?
Work on global clinical and post-marketing safety programs
Exposure to regulatory submissions across multiple health authorities
Structured career development, technical training, and leadership support
Inclusive, diverse, and performance-driven work culture
Opportunity to contribute to therapies impacting patients globally
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to diversity, equity, and inclusion. Employment decisions are made without regard to race, gender, disability, age, or any other protected status, in compliance with applicable laws.
Apply now on thepharmadaily.com to advance your career in Pharmacovigilance and Drug Safety with a global biopharmaceutical leader.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
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 :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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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 :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
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 :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
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 :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
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 :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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 | Mississauga | Uxbridge | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |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 :
Tartu | Estonia |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 :
Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva | Yavne |Remote :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Jeddah | King Abdullah Economic City | Riyadh | Khulais | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |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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