IQ
IQVIA RDS GmbH2 Tage
Local Pharmacovigilance Responsible Person(m/w/x)
Teilzeit
Senior
Keine Angabe
Frankfurt am Main
Nejo KI-Zusammenfassung
In this part-time role, you will be the go-to person for pharmacovigilance in Germany, ensuring compliance with regulations and acting as a liaison with health authorities. Your day-to-day responsibilities will include managing processes, providing training, and driving improvements in pharmacovigilance practices.
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Anforderungen
- •Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field
- •Minimum 5 years in pharmacovigilance or drug safety within a pharmaceutical company or CRO
- •At least 3 years of experience in PV system management and regulatory compliance
- •Previous experience as LCPP or similar role in Germany strongly preferred
- •In-depth understanding of EU and German PV regulations
- •Strong knowledge of PV agreements, PSMF, and risk management processes
- •Excellent communication skills in English and German
- •Strong organizational and time management skills
- •Effective stakeholder management and relationship-building skills
- •Ability to lead process improvement initiatives globally
- •Availability for 24/7 contact as required by German PV regulations
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Act as the Local Contact Person for Pharmacovigilance in Germany, available 24/7 for urgent safety issues
- •Ensure compliance with German pharmacovigilance requirements and local reporting obligations
- •Maintain local pharmacovigilance documentation
- •Serve as the primary interface with German health authorities for pharmacovigilance queries and inspections
- •Stay updated on local regulatory changes and implement necessary updates to pharmacovigilance processes
- •Support the EU Qualified Person for Pharmacovigilance in overseeing the pharmacovigilance system
- •Ensure alignment with the Pharmacovigilance System Master File
- •Own and manage assigned global pharmacovigilance processes, ensuring consistency and compliance across regions
- •Develop and maintain global standard operating procedures, templates, and guidance documents
- •Drive process improvements and harmonization initiatives with cross-functional teams
- •Provide expert advice and training to internal stakeholders on global pharmacovigilance processes
- •Prepare and maintain Pharmacovigilance System Master Files and local annexes for Germany
- •Oversee the development and negotiation of pharmacovigilance agreements for assigned clients
- •Act as EU Qualified Person for Pharmacovigilance for small clients, where applicable
- •Mentor and train team members on pharmacovigilance processes and regulatory requirements
- •Support audits and inspections at global and local levels
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA RDS GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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