Position: Quality Specialist for Global Pharmacovigilance & Drug Safety
Location: Madrid.
Experience: +5 years industrial experience in either pharmacovigilance or in a QA department interfaced with pharmacovigilance and clinical operations. A proven track record for the performance of audits, preferably GVP / GCP.
What are we looking for?
We are searching for a Quality Specialist to maintain and assist the EU QPPV with the development of the Quality Management System for Global Pharmacovigilance in the individual business units of Insud Pharma.
The challenge!
* Take responsibility of the audit plan in collaboration with the EU QPPV for the business units of InsudPharma.
* Performance of audits and qualifications and periodic follow-ups of service providers, business partner and commercial suppliers.
* Establish, improve and maintain the Global QMS system (SOPs, Policies, Guidance’s and WIs) on behalf of pharmacovigilance for the business units in InsudPharma.
* Assist in the handling of partner audits, CAPA resolutions, deviations, complaints and change control procedures.
* Assist the EU QPPV with the periodic measurements of the performance of the quality management system (metrics).
* Provide support as requested in the maintenance of the Pharmacovigilance System Master File (PSMF) and the pharmacovigilance surveillance activities in place for monitoring patient safety for marketed products.
* Establish and maintain collaborations with other departments and business units in Insud Pharma, affiliates and business partners to ensure a consistent interpretation and effective implementation of quality standards.
* Provide quality assurance support as requested to the function for clinical operations and the execution of interventional clinical studies conducted under GCP.
* Collaborate with Insud Pharma’s PV teams as requested to ensure the quality standards for global pharmacovigilance departments fulfil the regulations described in ICH guidance’s and fulfil standards described for GVP, GCP or local laws in collaboration with the EU QPPV.
* Attend relevant conferences and scientific meetings to stay updated with emerging law, regulations and guidelines and assure process compliance with applicable guidelines and standards for safety reporting.
* Provide support and guidance on the choice of service providers and IT solutions to support pharmacovigilance processes.
* Provide support to ensure an effective and cooperative cross-functional teamwork at the local, regional, and global levels.
What do you need?
* Languages: Fluent in English; intermediately in Spanish.
* Experience (years / area): +5 years industrial experience in either pharmacovigilance or in a QA department interfaced with pharmacovigilance and clinical operations. A proven track record for the performance of audits, preferably GVP / GCP.
* Specific Knowledge: In-depth knowledge of ISO 9001:2015, GVP and / or GCP.
* Travels: Willing to travel.
* Personal skills: Initiative and proactivity, ability to make decisions autonomously, decisiveness, people management skills, sense of responsibility, excellent communication skills.
* Flexible start time from Monday to Friday (full-time 40 hours).
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