Safety & Pharmacovigilance (PV) Coordinator – Hyderabad (Office-Based)
Location: Hyderabad, India (Office-Based)
Experience Required: Minimum 1 Year in Pharmacovigilance (PMS & Spontaneous Case Processing)
Education: B.Pharm or M.Pharm (Mandatory)
Industry: Pharmacovigilance | Drug Safety | Clinical Research
Job ID: 25105305
Job Overview
A globally recognized biopharmaceutical solutions organization is seeking a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad office. This position is ideal for candidates with practical experience in post-marketing surveillance (PMS), spontaneous adverse event case processing, and Individual Case Safety Reports (ICSRs).
The role involves managing safety data, ensuring regulatory compliance, supporting global pharmacovigilance operations, and maintaining high standards aligned with ICH, GVP, and international drug safety regulations.
Key Responsibilities
Process and track Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans.
Perform ICSR triage and evaluate case data for completeness, accuracy, and regulatory reportability.
Enter safety data into pharmacovigilance databases (LSMV preferred; Argus acceptable).
Conduct MedDRA coding for adverse events, indications, medical history, concomitant medications, and laboratory tests.
Prepare complete and regulatory-compliant narrative summaries.
Identify missing information, generate queries, and ensure timely follow-up.
Support expedited safety reporting in compliance with global regulatory requirements.
Perform literature screening and safety review activities.
Maintain drug dictionaries and perform manual recoding of un-coded product and substance terms.
Validate and submit xEVMPD product records, including MedDRA coding of indication terms.
Identify and manage duplicate ICSRs.
Support SPOR and IDMP activities.
Conduct quality review of ICSRs to ensure compliance and accuracy.
Ensure submission of relevant documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with ICH GCP, GVP, global drug/biologic/device regulations, and internal SOPs.
Participate in audits and inspection readiness activities.
Apply regulatory intelligence updates to ongoing safety reporting processes.
Required Experience and Qualifications
Minimum 1 year of experience in Pharmacovigilance, specifically in PMS and spontaneous case processing.
Hands-on experience with safety databases such as LSMV (preferred) or Argus.
Strong knowledge of MedDRA coding and medical terminology.
Understanding of clinical trial safety requirements (Phase II–IV) and post-marketing pharmacovigilance regulations.
Familiarity with ICH GCP, GVP, and global safety reporting guidelines.
Education: B.Pharm or M.Pharm (mandatory requirement).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and collaborative platforms.
Strong attention to detail with high accuracy standards.
Ability to manage multiple tasks and meet regulatory deadlines.
Effective written and verbal communication skills.
Ability to work independently and within cross-functional teams.
Organization Overview
The organization operates across 110+ countries with a workforce of over 29,000 professionals. In the past five years, it has supported 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to more than 200 clinical studies across 73,000 sites and 675,000+ clinical trial patients globally.
The company emphasizes regulatory excellence, diversity, inclusion, and a patient-centric approach to clinical development.
Job Summary
The Safety & PV Coordinator plays a critical role in global pharmacovigilance operations by ensuring accurate case processing, regulatory-compliant safety reporting, MedDRA coding, and database management. The position supports both clinical trial and post-marketing drug safety activities in alignment with international regulatory standards.
About ThePharmaDaily.com
ThePharmaDaily.com connects qualified pharmacovigilance and clinical research professionals with verified global opportunities in drug safety, regulatory affairs, medical writing, and pharmaceutical development.
Qualified candidates with relevant pharmacovigilance experience are encouraged to apply.
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