Safety & PV Specialist I — Syneos Health
Job Overview
Entry-level Pharmacovigilance (PV) role focused on adverse event case processing, safety database management, and regulatory compliance for clinical and post-marketing studies.
Location: Hyderabad, India
Job ID: 25107802
Job Family: Pharmacovigilance & Safety
Employment Type: Full-time
Role Summary
Responsible for end-to-end ICSR (Individual Case Safety Report) processing, including data entry, case triage, coding, and regulatory reporting support in compliance with global PV standards.
Key Responsibilities
1. Case Processing (ICSR Management)
Enter safety case information into PV tracking and safety databases
Process ICSRs as per SOPs and study safety plans
Triage cases for completeness, accuracy, and reportability
Generate narrative summaries for cases
Ensure timely expedited safety reporting
2. Coding & Data Management
Code medical events, medications, medical history, and lab data using MedDRA
Maintain drug dictionary and coding consistency
Perform manual recoding of safety data when required
Identify and resolve duplicate ICSRs
3. Quality & Compliance
Perform quality review of ICSRs
Ensure adherence to SOPs, GVP, ICH-GCP, and regulatory requirements
Maintain compliance with pharmacovigilance system documentation (TMF/PV Master File)
Support audit readiness activities
4. Literature & Regulatory Support
Perform literature screening for safety signals
Support xEVMPD, SPOR, and IDMP-related activities
Assist in regulatory safety reporting and tracking systems
5. Collaboration & Communication
Work with internal and external project teams
Support safety reporting across clinical and post-marketing studies
Participate in audits and inspections as needed
Required Qualifications
Education
Bachelor’s degree in Life Sciences / Nursing / Pharmacy
Or equivalent education and relevant experience
Experience
2–4 years experience in ICSR case processing (mandatory)
Experience in:
Spontaneous reporting cases
Clinical trial safety cases
Literature cases
Post-marketing case processing experience required
Technical Skills
Safety databases (Argus or similar)
MedDRA coding knowledge
Drug dictionary maintenance
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Knowledge Requirements
Good understanding of:
Pharmacovigilance (PV) processes
Clinical trial phases (II–IV)
Post-marketing safety reporting
ICH-GCP and GVP guidelines
Soft Skills
Strong attention to detail
Good organizational and multitasking ability
Ability to meet strict deadlines
Strong written and verbal communication
Ability to work independently and in teams
Career Level
Entry to mid-level PV specialist role
Focus on operational case processing and compliance execution
Job Impact
Ensures accurate reporting of adverse events
Supports global drug safety surveillance
Maintains regulatory compliance in pharmacovigilance systems
Contributes to patient safety across clinical and marketed products
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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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Istanbul | Turkey |Norway :
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Brinny | Ringaskiddy |Carlow :
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Cork | Dublin | Limerick | Waterford |Ulster :
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Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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South Yarra |United Kingdom :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
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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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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