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Safety & Pv Specialist I

0-2 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 & Pharmacovigilance Specialist I
Location: Hyderabad, India (Asia Pacific)
Category: Pharmacovigilance / Drug Safety
Company: Syneos Health
Job ID: 25001642


Job Description:

As a Safety & Pharmacovigilance (PV) Specialist I at Syneos Health, you’ll play an essential role in ensuring drug safety and regulatory compliance during clinical trials and post-marketing activities. Working in a collaborative and dynamic global environment, your responsibilities will support patient safety and enhance data integrity across global biopharmaceutical studies.


Why Syneos Health?

  • Global organization with 29,000 employees in 110 countries

  • Passionate focus on career growth, learning, and progression

  • Inclusive Total Self culture that supports authenticity and diversity

  • Leading provider for 94% of all FDA novel drug approvals over the last 5 years

  • Work that matters everywhere – with impact across healthcare innovation


Key Responsibilities:

  • Enter and manage data in Pharmacovigilance (PVG) tracking systems

  • Process and triage Individual Case Safety Reports (ICSRs)

  • Code medical terms (e.g., events, history, medications) and compile narratives

  • Query and follow up on incomplete or unclear safety data

  • Ensure accurate and timely regulatory submissions

  • Perform literature screening, MedDRA coding, and xEVMPD submissions

  • Identify and manage duplicate ICSRs

  • Quality review of case reports and proper documentation in TMF

  • Maintain compliance with SOPs, GCP, GVP, ICH, and regulatory requirements

  • Collaborate with internal and external project team members

  • Participate in audits and apply global safety regulatory intelligence


Qualifications:

  • Bachelor’s Degree in life sciences, nursing, pharmacy, or equivalent field

  • Familiarity with safety databases and medical terminology

  • Understanding of clinical trial phases (II–IV) and post-marketing safety processes

  • Proficiency in Microsoft Office Suite, Visio, Outlook, and content management tools

  • Strong communication, organizational, and time-management skills

  • Ability to multitask and work both independently and collaboratively

  • High attention to detail and ability to meet deadlines


Additional Information:

  • This job description is not exhaustive; other duties may be assigned as required

  • Equivalent education or experience may be considered

  • Syneos Health is an equal opportunity employer, committed to compliance with local and international employment laws