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Safety & Pv Coordinator (Hyderabad)

0-2 years
Not Disclosed
10 March 6, 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

Safety & Pharmacovigilance Coordinator

Company: Syneos Health
Location: Hyderabad (Raheja Mindspace)
Job ID: 25001478
Updated: Today

Job Description:

Key Responsibilities:

  • Monitor and route incoming information to relevant projects.
  • Record and track all ICSR documentation per sponsor/customer specifications.
  • Redact patient-identifying information in compliance with data protection guidelines, ICH GCP, and GVP.
  • Enter data into the safety database following company and sponsor-specific guidelines.
  • Ensure adherence to conventions when entering cases into the safety database.
  • Manage translation processes for source documents when required.
  • Assist in query follow-ups and submission processes.
  • Support literature screening and review for safety, MedDRA coding, and drug dictionary maintenance.
  • Assist in narrative writing and event coding (medical history, medications, and tests).
  • Support the timely and accurate reporting of expedited reports as per regulatory requirements.
  • Validate xEVMPD product records and manage duplicate ICSRs if necessary.
  • Ensure submission of documents to Trial Master File (TMF) and Pharmacovigilance System Master File.
  • Maintain knowledge of SOPs, regulatory guidelines, GCP, ICH, and Good Pharmacovigilance Practices (GVP).
  • Collaborate professionally with internal and external project team members.
  • Participate in audits and apply regulatory intelligence to safety reporting activities.

Qualifications:

  • Education: Bachelor’s Degree in Life Sciences, Nursing, Pharmacy, or equivalent experience.
  • Preferred Skills:
    • Familiarity with Safety Database systems and medical terminology.
    • Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook, and TeamShare.
    • Strong organizational, documentation, and attention to detail.
    • Ability to prioritize multiple tasks and work collaboratively within a team.
    • Excellent written and verbal communication skills.

About Syneos Health:

  • A fully integrated biopharmaceutical solutions organization operating in 110+ countries.
  • Collaborated on 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products in the past five years.
  • Committed to fostering an inclusive and supportive work culture.