Instagram
youtube
Facebook

Safety & Pv Coordinator (Hyderabad)

0-2 years
Not Disclosed
10 March 7, 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 & PV Coordinator - Hyderabad

Location: Hyderabad, India
Job Type: Full-Time (On-Site)
Job ID: 25001478

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. With 29,000 employees across 110 countries, we drive innovation and efficiency in clinical development.

Job Responsibilities:

  • Monitor and route incoming information to the appropriate project.
  • Record and track all ICSR documentation as per sponsor/customer specifications.
  • Redact patient identifying information in compliance with ICH GCP and GVP guidelines.
  • Enter data into the safety database, ensuring adherence to sponsor-specific guidelines.
  • Perform file creation, tracking, retention, and maintenance (paper & electronic).
  • Manage the translation process for source documents if required.
  • Assist with the query follow-up process as instructed.
  • Support submission processes and daily workflow reconciliation.
  • Assist with literature screening, safety data review, MedDRA coding, and maintenance of the drug dictionary.
  • Assist with narrative writing and coding of medical history, medications, and tests.
  • Support the generation and submission of expedited reports per regulatory requirements.
  • Validate xEVMPD product records, ensuring correct MedDRA coding where applicable.
  • Identify and manage duplicate ICSRs.
  • Participate in SPOR / IDMP activities if required.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as per regulatory requirements.
  • Maintain a thorough understanding of SOPs, GCP, GVP modules, study plans, and drug development processes.
  • Foster professional working relationships with all project team members.
  • Participate in audits and regulatory inspections as required.
  • Apply safety reporting regulatory intelligence to all safety-related activities.

Qualifications:

Education & Experience:

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent field.
  • Experience with Safety Database systems and medical terminology preferred.

Technical Skills:

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio).
  • Familiarity with TeamShare or other content management systems.

Soft Skills:

  • Strong teamwork and collaboration skills.
  • Ability to prioritize and multitask efficiently.
  • Excellent written and verbal communication.
  • High level of attention to detail and accuracy.
  • Strong organizational and documentation skills.

Why Join Syneos Health?

  • Career growth and professional development opportunities.
  • Supportive and engaged line management.
  • Total Self Culture: A workplace where you can be yourself.
  • Competitive total rewards program.