Pharmacovigilance Audit and Inspection Readiness Expert Opella

3.0 - 7.0 years

0 Lacs

hyderabad, all india

On-site

As a Pharmacovigilance Audit and Inspection Readiness Expert at Opella, you will play a crucial role in ensuring the ongoing permanent inspection preparedness and readiness of PV Operations in anticipation of regulatory inspections and audits. Your responsibilities will include active involvement in the preparation, conduct, and follow-up of GxP regulatory inspections impacting PV Operations, as well as organizing support for Global Quality audits and Business Partner audits. You will be responsible for tracking PV-related CAPAs, preparing for inspections and audits, collaborating with countries for audit readiness, and facilitating responses to audit findings. Additionally, you will support...

Posted 1 month ago

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Pharmacovigilance Analyst Clariwell Global

0.0 - 4.0 years

0 Lacs

nagpur, maharashtra

On-site

As a Safety Specialist, your primary responsibility will be to receive, triage, and process individual case safety reports (ICSRs) in a timely manner. You will accurately enter event data into PV databases and code medical terms using MedDRA / WHO-DD codes. It will be your duty to assess the seriousness, causality, and expectedness of cases, as well as conduct literature surveillance to identify potential safety signals. Additionally, you will play a key role in assisting with the preparation of case narratives, reports, and documentation. You will support the creation of aggregate safety reports such as PSURs and RMPs. Ensuring strict adherence to SOPs and regulatory standards will be cruci...

Posted 3 months ago

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Pharmacovigilance Audit and Inspection Readiness Expert Opella

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As a Pharmacovigilance Audit and Inspection Readiness Expert at Opella in Hyderabad, you will play a vital role in ensuring the ongoing preparedness and readiness of Pharmacovigilance (PV) Operations for regulatory inspections and audits. Your responsibilities will include actively participating in inspection preparedness, organizing support for quality audits, and following up on audit findings through to closure. You will collaborate with global teams, manage CAPAs related to audits and inspections, and track deviations to ensure timely resolution. In this role, you will prepare for PV inspections from an operational perspective, facilitate responses to audit findings, and conduct mock ins...

Posted 3 months ago

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