2.0 - 4.0 years

2 - 2 Lacs

hyderabad, sanathnagar

Work from Office

The Drug Safety Associate will process drug safety data, perform case processing, and contribute to safety signal detection and risk management activities. Roles & Responsibilities: Collect, review, and process Individual Case Safety Reports (ICSRs) from spontaneous reports, literature, and clinical trials. Enter safety data into pharmacovigilance databases (e.g., Argus). Perform MedDRA and WHO-Drug coding of AEs and medications. Conduct literature screening for safety events. Support aggregate safety reports (PSUR, PBRER, DSUR). Assist in signal detection, risk-benefit analysis, and risk management plans. Ensure compliance with global PV regulations (US FDA, EMA, CDSCO, MHRA). Coordinate wi...

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Medical Writer Hetero

2.0 - 4.0 years

2 - 2 Lacs

hyderabad, sanathnagar

Work from Office

The Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions. Roles & Responsibilities: Draft, review, and finalize clinical study protocols, investigator brochures, informed consent forms, and clinical study reports (CSRs). Prepare regulatory submission documents (CTD modules, IND, NDA, MAA dossiers). Write manuscripts, abstracts, and posters for publication/presentation. Ensure compliance with ICH-GCP, FDA, EMA, CDSCO, and other regulatory authority guidelines. Collaborate with clinical, pharmacovigilance, regulatory, and biostatistics teams. Perform literature search and develop su...

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Clinical Research Associate ( CRA ) Hetero

2.0 - 4.0 years

2 - 2 Lacs

hyderabad, sanathnagar

Work from Office

The Clinical Research Associate will oversee clinical trial activities to ensure ethical conduct, regulatory compliance, and high-quality data generation. Roles & Responsibilities: Assist in planning, initiation, execution, and closure of clinical trials. Conduct site monitoring visits (site selection, initiation, monitoring, close-out). Ensure adherence to study protocols, ICH-GCP, and regulatory requirements. Manage informed consent process and patient safety reporting. Coordinate with investigators, site staff, and CROs. Review Case Report Forms (CRFs) for accuracy and completeness. Track study timelines, budgets, and milestones. Support inspection readiness and audit activities. Maintain...

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