Safety & PV Specialist I (Gurugram – Night Shift)
Company: Syneos Health
Location: Gurugram, Haryana, India
Work Mode: Office-Based (Night Shift)
Employment Type: Full-Time
Job Overview
The Safety & PV Specialist I is responsible for end-to-end pharmacovigilance case processing activities, including ICSR intake, data entry, coding, narrative writing, quality review, and regulatory safety reporting. The role ensures compliance with global pharmacovigilance regulations, SOPs, and client-specific safety requirements while supporting accurate and timely drug safety reporting in a CRO environment.
Key Responsibilities
Process Individual Case Safety Reports (ICSRs) in compliance with SOPs and project safety plans
Perform case triage, completeness checks, and regulatory reportability assessments
Enter and maintain safety data in pharmacovigilance databases and tracking systems
Code adverse events, medical history, concomitant medications, and laboratory tests using MedDRA
Prepare and review narrative case summaries
Identify missing data and follow up with stakeholders to resolve queries
Support expedited and periodic safety reporting as per global regulatory requirements
Perform literature screening and drug safety review activities
Handle duplicate case detection and reconciliation activities
Support xEVMPD submissions, SPOR, and IDMP-related activities
Ensure TMF and Pharmacovigilance System Master File (PSMF) compliance
Perform quality review of ICSRs and ensure data accuracy
Participate in audits and inspection readiness activities
Maintain safety tracking and reporting timelines
Collaborate with global cross-functional teams in pharmacovigilance operations
Required Qualifications
B.Pharm / M.Pharm / BDS / BMS / MBBS only (BSc/MSc not eligible)
Strong understanding of pharmacovigilance principles and drug safety processes
Knowledge of ICH-GCP, GVP, and global regulatory requirements
Familiarity with MedDRA coding and safety databases
Strong attention to detail and documentation skills
Willingness to work in night shifts
Preferred Qualifications
Prior CRO or pharmaceutical PV case processing experience
Exposure to ICSR processing and safety reporting systems
Understanding of xEVMPD, SPOR, and IDMP frameworks
Experience supporting audits or regulatory inspections
Knowledge of global drug safety reporting workflows
Experience Required
Minimum 2.6+ years of experience in Pharmacovigilance / Drug Safety / ICSR processing
Hands-on experience in case processing, coding, or safety database management preferred
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
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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 :
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Japan | Saitama |Tokyo :
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