Safety Science Coordinator I – Pharmacovigilance & Drug Safety
Location: Pune, India
Job Type: Full-Time
Category: Clinical Safety / Pharmacovigilance
Experience Required: 0 to 2 years
Job Overview
The Safety Science Coordinator I supports clinical safety and pharmacovigilance operations by managing adverse event reporting and safety data processes across clinical trials and post-marketing activities. This role is responsible for ensuring accurate, timely, and compliant processing of safety data, including expedited reporting to regulatory authorities and stakeholders. The position requires close collaboration with cross-functional teams to maintain high-quality safety standards while adhering to global regulatory requirements and internal procedures.
Key Responsibilities
Support the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) in compliance with regulatory timelines and study requirements. Maintain and manage adverse event tracking systems, ensuring all incoming adverse event and serious adverse event reports are accurately logged and processed. Perform data entry of safety information into safety databases and tracking tools, ensuring completeness and accuracy. Assist in writing patient narratives and coding adverse events using MedDRA terminology where applicable. Support listedness assessment against product labeling and generate queries to resolve missing or inconsistent data in collaboration with medical teams. Facilitate timely submission of expedited safety reports to regulatory authorities, ethics committees, investigators, and sponsors. Assist in reconciliation activities between safety databases and other clinical systems to ensure data consistency. Contribute to quality review processes, including peer review of safety cases and identification of trends or discrepancies. Maintain safety documentation and ensure compliance with global pharmacovigilance regulations, SOPs, and quality management systems. Support preparation and archiving of safety study files at project completion. Coordinate internal and external meetings and provide administrative support to pharmacovigilance teams. Participate in training and mentoring activities for junior staff and peers as required. Build strong cross-functional relationships to support efficient safety operations and compliance.
Education and Qualifications
Bachelor’s degree, Associate degree, or equivalent qualification in Life Sciences, Pharmacy, Nursing, or a related healthcare discipline is preferred. PharmD candidates with internship or limited safety experience are encouraged to apply. Equivalent experience in pharmaceutical, biotechnology, or CRO environments may be considered in lieu of formal education.
Experience Requirements
0 to 2 years of experience in pharmacovigilance, clinical safety, or related domains is required. Candidates should have exposure to adverse event processing, safety databases, or regulatory reporting processes.
Key Skills and Competencies
Basic understanding of pharmacovigilance processes, including AE/SAE reporting and regulatory requirements. Strong attention to detail with the ability to manage and process large volumes of safety data accurately. Good written and verbal communication skills with the ability to collaborate effectively in team environments. Ability to prioritize tasks and manage multiple activities within defined timelines. Familiarity with MedDRA coding and safety databases is an advantage. Proficiency in Microsoft Office tools and general computer applications. Strong analytical and organizational skills with a focus on quality and compliance.
Work Environment
This role operates in a professional office or remote working environment, depending on business requirements.
Why Join This Role
This is an excellent opportunity for early-career professionals to build expertise in pharmacovigilance and drug safety within a global clinical research environment. The role offers exposure to regulatory processes, safety reporting systems, and cross-functional collaboration, enabling strong career growth in clinical safety and drug development.
Uttar Pradesh :
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