Sr. Safety & PV Specialist
Company: Syneos Health
Location: Hyderabad / Gurugram, India (Office-Based)
Job ID: 25107898
Updated On: July 2, 2026
Job Summary
Syneos Health is hiring a Senior Safety & Pharmacovigilance (PV) Specialist to manage end-to-end ICSR case processing, quality review (QC), safety data management, regulatory reporting, and pharmacovigilance compliance. The role involves handling individual case safety reports, MedDRA coding, literature screening, xEVMPD submissions, SPOR/IDMP activities, and ensuring compliance with global pharmacovigilance regulations and clinical trial requirements.
Key Responsibilities
Process Individual Case Safety Reports (ICSRs) according to SOPs and project safety plans.
Receive, triage, and track ICSRs using pharmacovigilance quality systems.
Evaluate ICSRs for completeness, accuracy, and regulatory reportability.
Enter safety data into pharmacovigilance databases.
Perform MedDRA coding for adverse events, medical history, medications, and laboratory tests.
Prepare complete and accurate case narratives.
Identify missing information and follow up on safety queries.
Generate expedited safety reports in compliance with global regulatory timelines.
Maintain safety tracking and reporting records.
Perform literature screening and safety literature reviews.
Maintain drug dictionaries and perform drug coding.
Validate and submit xEVMPD product records.
Manage manual recoding of product and substance terms.
Identify and manage duplicate ICSRs.
Support SPOR and IDMP compliance activities.
Perform Quality Check (QC) and quality review of ICSR cases.
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation.
Ensure compliance with SOPs, ICH-GCP, GVP, FDA, EMA, and global pharmacovigilance regulations.
Participate in internal and external audits.
Collaborate with internal teams and sponsors on safety reporting activities.
Required Skills
Pharmacovigilance (PV)
ICSR Case Processing
ICSR Quality Check (QC)
Drug Safety
Safety Database Management
MedDRA Coding
WHO Drug Coding
Narrative Writing
Expedited Safety Reporting
xEVMPD Submission
SPOR / IDMP
Literature Screening
Duplicate Case Management
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
FDA, EMA & Global PV Regulations
ICH-GCP & GVP Compliance
Microsoft Office Suite
Attention to Detail
Communication & Analytical Skills
Eligibility
B.Pharm
M.Pharm
BDS
BMS
MBBS
Note: B.Sc. and M.Sc. candidates are not eligible.
Experience
Required Experience: Minimum 6 years of experience in Pharmacovigilance (PV) with mandatory ICSR Case Processing and Quality Check (QC) experience. Immediate or early joiners are preferred.
Salary Package (Estimated Market Standard)
₹12 LPA – ₹18 LPA (depending on experience, pharmacovigilance expertise, and interview performance).
Work Mode
Office-Based
Hyderabad or Gurugram Location
Why Join Syneos Health?
Opportunity to work on global pharmacovigilance and drug safety projects.
Exposure to international regulatory authorities and advanced safety reporting systems.
Career development through technical and leadership training.
Collaborative and inclusive work environment.
Employee recognition and growth opportunities.
Chance to contribute to global patient safety and drug development programs.
About Syneos Health
Syneos Health is a leading global life sciences organization that partners with pharmaceutical, biotechnology, and healthcare companies throughout the drug development and commercialization lifecycle. Over the past five years, the company has contributed to 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and supported 200+ clinical studies across 73,000 sites involving more than 675,000 clinical trial participants.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Bulgaria | Vedant |Denmark :
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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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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
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Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Green Way | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Victoria | Remote - South America (Latin Americal) | Blue Bell | Tulsa | Ireland | Minnesota | Castlebar | French | Zaragoza | Perth | Remote - Middle East | Hammond | Bountiful | Bishop | Lenexa | Remote - Europe | Slovakia | Texas | Leinster | Xzagreb | Nairobi | Springville | Faridabad | Hungary | Medan | Switzerland | Thailand | Remote - Africa | Lousiana | Manipal | Milwaukee | Belgium | McFarland | Melbourne |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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King Abdullah Economic City | Jeddah | Najran | Riyadh | Khulais | Rabigh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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