Company: Syneos Health
Job Location: Hyderabad / Gurugram / Pune, India
Job Type: Full-Time | Office-Based
Department: Drug Safety & Pharmacovigilance
Experience Required:
Safety & PV Specialist I – Minimum 2.6 Years
Safety & PV Specialist II – Minimum 4 Years
Freshers Eligible: YES
Preferred Candidates: Immediate Joiners
About the Company
Syneos Health is a leading global life sciences and clinical research organization focused on accelerating customer success across the drug development lifecycle. The company partners with pharmaceutical, biotechnology, and healthcare innovators worldwide to support clinical development, pharmacovigilance, medical affairs, and commercialization activities.
With operations across multiple countries and involvement in the majority of recent FDA-approved therapies, Syneos Health offers professionals the opportunity to work on high-impact global healthcare programs.
Job Overview
Syneos Health is hiring experienced Pharmacovigilance professionals for the role of Safety & PV Specialist I / II in India. This opportunity is ideal for candidates with hands-on experience in ICSR processing, drug safety operations, MedDRA coding, literature review, and global pharmacovigilance compliance.
Candidates should possess strong knowledge of global safety regulations, case processing workflows, expedited reporting requirements, and pharmacovigilance databases.
Key Responsibilities
Perform end-to-end Individual Case Safety Report (ICSR) processing according to global SOPs and project-specific safety plans
Review and triage adverse event reports for completeness, seriousness, expectedness, and reportability
Enter and maintain accurate safety data in pharmacovigilance databases
Conduct MedDRA coding for adverse events, medical history, laboratory tests, and concomitant medications
Prepare detailed and medically accurate narrative summaries
Identify missing or inconsistent information and follow up with relevant stakeholders for query resolution
Support expedited reporting activities in compliance with global regulatory timelines
Perform literature screening and safety review activities
Handle duplicate case identification and reconciliation activities
Participate in xEVMPD validation and submission activities
Support SPOR and IDMP-related pharmacovigilance processes
Conduct quality review and compliance checks for ICSRs
Maintain Trial Master File (TMF) documentation and pharmacovigilance records
Ensure adherence to ICH-GCP, GVP guidelines, regulatory requirements, and company SOPs
Collaborate with internal and external stakeholders across global drug safety projects
Participate in audits, inspections, and regulatory readiness activities
Educational Qualification
Eligible Qualifications:
B.Pharm
M.Pharm
BDS
BMS
MBBS
Not Eligible:
BSc
MSc
Required Skills
Strong understanding of pharmacovigilance workflows and global safety reporting requirements
Expertise in ICSR processing and adverse event case management
Knowledge of MedDRA coding, WHO Drug Dictionary, and safety databases
Familiarity with ICH-GCP, GVP, FDA, EMA, and global regulatory guidelines
Good analytical, documentation, and communication skills
Ability to work in fast-paced global safety projects
Who Should Apply?
This role is suitable for experienced Pharmacovigilance professionals looking to advance their careers in global drug safety operations, case processing, and regulatory pharmacovigilance.
Freshers are not eligible for this opening. Candidates must have prior hands-on experience in pharmacovigilance case processing or related drug safety activities.
Why Join Syneos Health?
Opportunity to work with one of the world’s leading clinical research and pharmacovigilance organizations
Exposure to global pharmaceutical and biotechnology projects
Career growth in drug safety, regulatory compliance, and clinical development
Collaborative and innovation-driven work culture
Strong learning and professional development environment
Uttar Pradesh :
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Remote, India | 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 :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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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 :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | North York | Australia | Uxbridge | Richmond Hill | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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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 :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Be'Er Sheva | Tel Aviv | Yavne | Kfar Saba |Remote :
Remote, USA | Blue Bell | Remote | Switzerland | Thailand | Victoria | Belgium | Lousiana | Remote - Middle East | Nairobi | Zaragoza | Hammond | Remote - South America (Latin Americal) | Minnesota | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Bountiful | Ireland | Green Way | Lenexa | Leinster | Remote - Europe | French | Slovakia | Castlebar | Xzagreb | Tulsa | Manipal | McFarland | Hungary | Melbourne | Texas | Bishop | Remote - Africa | Faridabad | Medan | Springville |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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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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