Company Overview
Syneos Health is a global fully integrated clinical research and life sciences services company supporting drug development and commercialization. The organization works across the clinical development continuum to improve patient outcomes through high-quality safety, regulatory, and clinical operations services.
Job Details
|
Category |
Details |
|---|---|
|
Job Title |
Senior Safety and Pharmacovigilance Specialist (QC Experience) |
|
Company |
Syneos Health |
|
Job ID |
25107316 |
|
Location |
Gurugram / Hyderabad (Office-Based) |
|
Function |
Pharmacovigilance / Drug Safety |
|
Employment Type |
Full-Time |
|
Experience Required |
≥ 6 years PV experience |
|
QC Experience Required |
≥ 3 years Quality Control experience |
|
Education Requirement |
B.Pharm / M.Pharm / BDS / BMS / MBBS (BSc / MSc not eligible) |
Role Summary
The Senior Safety and PV Specialist is responsible for end-to-end pharmacovigilance case processing with a strong focus on Quality Control (QC). The role ensures accurate, timely, and compliant processing of Individual Case Safety Reports (ICSRs) and supports global regulatory safety reporting requirements across clinical trials and post-marketing programs.
The position requires expertise in case processing, medical coding, QC review, safety database management, and regulatory compliance.
Key Responsibilities
1. ICSR Processing & Data Management
Enter safety information into PV tracking and safety databases.
Process ICSRs as per SOPs and project-specific safety plans.
Ensure accurate case triage and data entry.
2. Quality Control (QC)
Perform QC review of ICSRs.
Ensure:
Data completeness
Accuracy
Regulatory reportability
Identify and resolve discrepancies in safety cases.
3. Medical Coding & Case Processing
Code:
Adverse events
Medical history
Concomitant medications
Lab/test data
Perform manual recoding of product and substance terms.
Support MedDRA coding and drug dictionary maintenance.
4. Narrative Writing & Documentation
Prepare complete and accurate narrative case summaries.
Maintain compliance with documentation standards.
Ensure submission of safety documents to:
Trial Master File (TMF)
Pharmacovigilance System Master File (PSMF)
5. Regulatory Reporting & Compliance
Support expedited safety reporting.
Ensure compliance with:
GVP (Good Pharmacovigilance Practices)
GCP (Good Clinical Practice)
ICH guidelines
Global regulatory requirements
Apply regulatory intelligence in safety reporting.
6. Safety Systems & Advanced PV Activities
Perform:
Literature screening for safety signals
MedDRA coding
Drug dictionary maintenance
Handle:
xEVMPD product records
SPOR / IDMP activities
Identify and manage duplicate ICSRs.
7. Quality & Audit Support
Participate in audits and inspections.
Maintain compliance with SOPs and Work Instructions.
Support quality metrics tracking and reporting.
8. Collaboration & Communication
Work closely with internal and external project teams.
Maintain professional relationships across functions.
Support cross-functional safety operations.
Required Qualifications
Education (Mandatory)
B.Pharm / M.Pharm / BDS / BMS / MBBS
❌ BSc / MSc not accepted
Experience
Minimum 6 years in Pharmacovigilance
Minimum 3 years in Quality Control (QC)
Experience in:
End-to-end ICSR case processing
Clinical trial and post-marketing PV
EDC systems exposure
Product/device complaint handling (preferred)
Technical Skills
Safety databases (ICSR processing tools)
MedDRA coding
Drug dictionaries
xEVMPD systems
SPOR / IDMP frameworks
Literature screening tools
PV quality tracking systems
Regulatory Knowledge
ICH guidelines
GVP compliance
GCP standards
Global pharmacovigilance regulations
SOP and PV system compliance
Soft Skills
Strong attention to detail
QC mindset and analytical ability
Strong documentation skills
Ability to manage multiple cases
Team collaboration and communication skills
Preferred Profile
Ideal candidates typically have experience in:
Pharmacovigilance Case Processing
Drug Safety QC
Post-marketing surveillance
Clinical trial safety reporting
MedDRA coding & data validation
Regulatory safety submissions
CRO / pharmaceutical PV environments
Safety data quality management
Work Environment & Benefits
Professional Environment
Syneos Health provides:
Global exposure to clinical safety programs
High-impact drug safety operations
Structured training and development
Cross-functional collaboration opportunities
Culture & Values
Inclusive and diverse workplace
Patient-focused mission (“Driven to Deliver”)
Performance-driven and innovation-oriented culture
Strong emphasis on employee development
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Netherlands |Remote Australia :
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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 | North York | Australia | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
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Argentina | Peru |Brazil :
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Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Prague |Chile :
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