Safety & Pharmacovigilance Specialist I – Medical Device & PQC
Company: Syneos Health
Location: Gurugram, India
Job Type: Full-Time | Office-Based
Experience: 2.5 – 4 Years
Qualification: B.Pharm / M.Pharm / PharmD / BDS / BMS / MBBS
(B.Sc / M.Sc not eligible)
Approx Salary: ₹6 LPA – ₹10 LPA
Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance Specialist I to support pharmacovigilance and product quality complaint (PQC) activities. The role involves end-to-end ICSR processing, safety data management, regulatory reporting support, and compliance with global pharmacovigilance guidelines. Candidates will work with safety databases, manage adverse event reporting, and ensure compliance with global drug, biologic, and medical device safety regulations.
Key Responsibilities
1. ICSR Processing & Case Management
Process Individual Case Safety Reports (ICSRs) according to SOPs and safety plans.
Enter and manage case information in safety databases such as Argus or ARISg.
Perform triage and evaluate cases for completeness, accuracy, and regulatory reportability.
Code adverse events, medical history, medications, and lab tests using MedDRA and relevant dictionaries.
Prepare detailed narrative summaries for safety cases.
Identify missing or inconsistent case information and follow up for resolution.
Detect and manage duplicate ICSRs and perform quality review of safety cases.
2. Regulatory Reporting & Compliance
Support preparation and submission of expedited safety reports in accordance with global regulatory requirements.
Validate and submit xEVMPD product records with appropriate MedDRA coding.
Perform manual recoding of uncoded product and substance terms from ICSRs.
Support SPOR / IDMP regulatory data management activities.
Maintain safety activity tracking and ensure documentation is submitted to Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as applicable.
3. Product Quality Complaint (PQC) Management
Handle PQC-related safety cases and ensure accurate documentation.
Monitor and track product quality complaints in pharmacovigilance systems.
Ensure compliance with global PV and quality regulations.
4. Literature Review & Safety Monitoring
Conduct literature screening for potential safety signals.
Maintain drug dictionaries and support coding activities.
Support safety evaluations and ongoing pharmacovigilance monitoring.
5. Audit & Stakeholder Collaboration
Ensure compliance with GCP, ICH guidelines, GVP, and global drug/device regulations.
Participate in internal audits and regulatory inspection readiness activities.
Collaborate with internal and external stakeholders to support pharmacovigilance operations.
Required Skills
Technical Skills
ICSR case processing and pharmacovigilance workflows
Knowledge of MedDRA coding and safety data management
Experience with Argus or ARISg safety database
Product Quality Complaint (PQC) case handling
Understanding of global pharmacovigilance regulations and reporting requirements
Soft Skills
Strong analytical and problem-solving skills
High attention to detail and regulatory compliance focus
Effective communication and teamwork abilities
Ability to manage multiple safety cases and deadlines
Preferred Skills
Knowledge of clinical trial phases II–IV and post-marketing safety monitoring
Experience with SPOR / IDMP regulatory data standards
Familiarity with safety reporting and pharmacovigilance regulatory frameworks
Role Impact
The Safety & PV Specialist I plays a crucial role in ensuring accurate safety case processing, regulatory compliance, and monitoring of product quality complaints, helping maintain drug and medical device safety standards while supporting global pharmacovigilance operations.
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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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
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Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Canada |Quebec :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
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 :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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