Safety & PV Coordinator – Hyderabad, India (Office-Based) | Minimum 1 Year Experience Required
Location: Hyderabad, India
Job ID: 25105305
Employment Type: Full-Time (Office-Based)
Experience Required: Minimum 1 year in Pharmacovigilance (PMS & Spontaneous Cases)
Education Required: B.Pharm or M.Pharm (Mandatory)
A leading global biopharmaceutical solutions organization is seeking a Safety & Pharmacovigilance (PV) Coordinator for its Hyderabad office. This role is designed for professionals with hands-on experience in post-marketing surveillance (PMS), spontaneous case processing, and Individual Case Safety Report (ICSR) management within regulated pharmacovigilance environments.
This position plays a critical role in ensuring regulatory compliance, patient safety, and high-quality safety data management across clinical and post-marketing programs.
Key Responsibilities
Enter and manage ICSR data in pharmacovigilance quality and tracking systems.
Assist in ICSR processing in accordance with SOPs and project-specific safety management plans.
Triage and evaluate ICSRs for completeness, accuracy, and regulatory reportability.
Perform data entry in safety databases and code adverse events, medical history, concomitant medications, and laboratory tests.
Compile comprehensive case narratives.
Identify missing information, raise queries, and follow up until resolution.
Support timely preparation and submission of expedited safety reports as per global regulatory requirements.
Maintain safety tracking logs for assigned projects.
Conduct literature screening and safety review activities.
Perform drug coding, MedDRA coding, and maintenance of drug dictionaries.
Validate and submit xEVMPD product records, including correct MedDRA indication coding.
Perform manual recoding of product and substance terms arising from ICSRs.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related pharmacovigilance activities.
Conduct quality review of ICSRs.
Ensure submission of relevant safety documentation to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with global drug, biologic, and device regulations including ICH-GCP and GVP guidelines.
Participate in audits as required.
Apply regulatory intelligence updates to ongoing safety reporting activities.
Required Qualifications
B.Pharm or M.Pharm (mandatory).
Minimum 1 year of experience in Pharmacovigilance, specifically in PMS and spontaneous case processing.
Experience with safety databases such as LSMV (preferred) or Oracle Argus.
Strong knowledge of ICSR lifecycle management.
Familiarity with MedDRA coding and medical terminology.
Understanding of clinical trial phases II–IV and post-marketing safety requirements.
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and document management systems.
Strong organizational skills with the ability to manage multiple tasks and deadlines.
High attention to detail and accuracy.
Strong written and verbal communication skills.
Ability to work independently and within cross-functional teams.
About the Organization
This global biopharmaceutical services provider operates in over 110 countries with approximately 29,000 employees. Over the past five years, the organization has supported:
94% of Novel FDA-approved drugs
95% of EMA-authorized products
200+ clinical studies
73,000 research sites
675,000+ clinical trial patients
The company promotes career growth, technical training, regulatory excellence, and a collaborative culture dedicated to accelerating therapy development and ensuring patient safety worldwide.
Role Overview
The Safety & PV Coordinator contributes directly to global pharmacovigilance operations by ensuring accurate ICSR processing, regulatory compliance, and high-quality safety reporting. This position is ideal for early-career pharmacovigilance professionals seeking structured growth within a global CRO environment.
Equal Opportunity Statement
The employer is committed to building a diverse, inclusive, and equitable workplace. Candidates with relevant experience and transferable skills are encouraged to apply. Reasonable accommodations are provided in accordance with applicable regulations.
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