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Safety & Pv Specialist I

1–2.5 years in Pharmacovigilance years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Hybrid Education: B.Pharm / M.Pharm / BDS / BMS / MBBS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧪 Job Title: Safety & PV Specialist I

Job ID: 25100771
Location: Gurugram, India (Hybrid)
Updated: August 20, 2025


🔍 About Syneos Health

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. With 29,000 employees across 110 countries, we combine clinical development, medical affairs, and commercial expertise to deliver high-impact results for our clients and patients.

Our model puts patients and customers at the center of everything we do, and we constantly strive to simplify, innovate, and improve the way we work—making us both easier to work with and for.


💡 Why Choose Syneos Health

  • Career Development & Growth
    Ongoing technical training, career pathing, and mentorship from engaged leadership.

  • Inclusive, Supportive Culture
    Our Total Self philosophy promotes authenticity and belonging.

  • Global Recognition

    • Worked on 94% of all Novel FDA Approved Drugs

    • Supported 95% of EMA Authorized Products

    • Contributed to 200+ studies, 73,000+ sites, and 675,000+ patients over the past 5 years

  • Diverse and Purpose-Driven Teams
    We celebrate differences in thought, background, and culture, enabling innovation and connection.


📝 Position Summary

As a Safety & Pharmacovigilance (PV) Specialist I, you will support the processing and tracking of individual case safety reports (ICSRs) and ensure compliance with global regulatory requirements and Syneos Health standards.


Key Responsibilities

🔄 ICSR Case Processing

  • Enter information into Pharmacovigilance (PVG) tracking systems.

  • Triage and evaluate ICSRs for completeness, accuracy, and regulatory reportability.

  • Enter and manage safety data in the database.

  • Code medical events, history, concomitant medications, and test results using MedDRA.

  • Compile narrative summaries and perform quality reviews of ICSRs.

  • Query missing/incomplete information and ensure resolution.

🧾 Regulatory Reporting

  • Generate and submit expedited safety reports according to regulations and SOPs.

  • Ensure submission of documents to TMF and Pharmacovigilance System Master File (PSMF).

📚 Data Management & Coding

  • Perform literature screening and drug dictionary maintenance.

  • Conduct manual re-coding of product and substance terms.

  • Validate and submit product records in xEVMPD (Extended EudraVigilance Medicinal Product Dictionary).

  • Support SPOR / IDMP activities.

🔍 Compliance & Documentation

  • Maintain up-to-date knowledge of SOPs, Work Instructions (WIs), ICH-GCP, GVP, and global safety regulations.

  • Ensure regulatory intelligence is applied to all reporting activities.

  • Contribute to internal and external audits, as required.

🤝 Team Collaboration

  • Foster collaborative, professional relationships with project team members and external stakeholders.


🎓 Qualifications

(Note: Not explicitly listed in this version. However, based on standard job profiles for this role at Syneos Health, the following is expected:)

  • Education (Preferred):
    B.Pharm / M.Pharm / BDS / BMS / MBBS
    (BSc / MSc not preferred for this position)

  • Experience:
    Typically 1–2.5 years in Pharmacovigilance (ICSR case processing experience preferred)

  • Skills:

    • Strong medical terminology knowledge

    • Familiarity with safety databases and MedDRA coding

    • Good written and verbal English communication skills

    • Attention to detail and analytical thinking


📌 Additional Information

  • This job description outlines general responsibilities and expectations. Tasks may evolve or be re-assigned at the company's discretion.

  • Syneos Health is committed to diversity, inclusion, and compliance with all global regulatory and employment laws, including the EU Equality Directive and Americans with Disabilities Act (ADA).

  • Reasonable accommodations will be provided for applicants or employees as needed.


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  • Apply Now

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