Pharmacovigilance Associate Cliniweb Services

0.0 - 4.0 years

0 Lacs

nagpur, maharashtra

On-site

In this role, you will be responsible for performing case intake of Individual Case Safety Reports (ICSRs) from various sources such as patients, healthcare professionals, and literature. Your key responsibilities will include entering and updating safety data accurately in pharmacovigilance databases, conducting initial assessment and triage of reported adverse events, and assisting in coding medical terms using MedDRA. Additionally, you will ensure timely and compliant reporting of safety cases to regulatory authorities and support the preparation of safety narratives and case summaries under supervision. You will also review source documents for accuracy and completeness, assist with sign...

Posted 1 week ago

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QA Auditor PV Navitas Life Sciences

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a QA Auditor - PV at our company, your role will involve the following responsibilities: - Implementing and maintaining the pharmacovigilance system, quality process, and metrics - Conducting audits of projects, systems, processes, and vendors as assigned - Supporting with preparation for hosting customer audit and PV inspections Qualifications required for this role include: - 5+ years of experience in Global PV System Management in pharmaceutical companies or PV Service Providers, demonstrating a strong understanding of PV principles and practices - 3+ years of experience in conducting GCP and GVP audits - Experience in CAPA Management - A strong understanding of GVP guidelines - 3+ yea...

Posted 1 month ago

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Medical Safety Expert Novartis India

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

Posted 4 months ago

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Regulatory Review Advisor - Global Business Services Astrazeneca

3.0 - 5.0 years

3 - 6 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Regulatory Reporting Compliance Ensure timely and accurate submission of regulatory reports, including Adverse Event Reports, Periodic Safety Update Reports, and other required documentation Interpret and apply global regulatory reporting requirements including those for health authorities Monitor updates to regulatory guidelines and ensure internal GBS processes align with evolving reporting standards Adverse Event and Safety Reporting Coordinate pharmacovigilance reporting activities, ensuring compliance with Good Pharmacovigilance Practices Work closely with safety teams to assess, process, and submit Individual Case Safety Reports within required timescales Assist in detection and risk a...

Posted 6 months ago

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