PV Safety Specialist

Role Summary

Ensure submission of periodic reports, where applicable, to local regulatory authorities in accordance with global processes and local authority requirements.

Oversight of Risk Management Plans (RMPs) and Additional Risk Minimization Measures (RMMs)

Oversee implementation of Risk Management Plans (RMPs) in collaboration with relevant teams, in accordance with Global Safety guidance and local regulatory requirements.

Monitor local distribution of additional Risk Minimization Measures (RMMs) and related compliance metrics.

Signal Detection

Conduct local signal detection activities and notify Global Safety of any potential local safety signals identified during routine pharmacovigilance activities.

Oversee review of signal assessment reports published by Global Safety on the WRA portal.

Safety Communications and Responses to Requests from National Competent Authorities

Ensure management of safety-related inquiries, significant safety issues, and, where applicable, local/global crisis management in compliance with global processes and local regulatory requirements.

Maintain oversight of safety communications directed to healthcare professionals or consumers, where applicable.

Provide the EU QPPV Office (Qualified Person Responsible for Pharmacovigilance) with all relevant information necessary for oversight and follow-up of requests, where applicable.

Remain informed of local regulatory requirements.

Labeling and Commitments

Ensure consideration of and contribute, where applicable, to local safety labeling updates in collaboration with local Regulatory Affairs.

Contribute to the implementation of regulatory commitments when applicable.

Pharmacovigilance Quality System

Establish and maintain a local pharmacovigilance quality system in accordance with global processes and local regulatory authority requirements.

Be responsible for training and awareness of relevant affiliate personnel and, where applicable, business partners or service providers, while maintaining compliance metrics for local training requirements.

Local Pharmacovigilance Agreements

Participate in the initiation, negotiation, drafting, implementation, and updating of local pharmacovigilance agreements with local partners or service providers.

Inform the Global Safety International Unit in advance of any locally established contract involving pharmacovigilance activities and/or impacting pharmacovigilance activities (including outsourcing arrangements with partner companies).

Ensure compliance with these agreements.

Provide timely feedback to the Global Safety International Unit regarding any changes known to the LPV (for example, changes to products covered under a pharmacovigilance agreement).

Business Continuity

Ensure continuity of local pharmacovigilance activities, including establishing an out-of-hours coverage system.

Regulatory Intelligence

Continuously monitor changes in local legislation, conduct impact assessments, and inform Global Safety of any relevant changes.

Archiving

Ensure pharmacovigilance documents are archived in compliance with local regulatory requirements and applicable data protection regulations.

Audits and Inspections

Notify Global Safety immediately upon receipt of an audit notification from a business partner or an inspection notice, and serve as the local point of contact.

Ensure implementation of CAPA (Corrective and Preventive Action) plans within established timelines.

Management of the Local Pharmacovigilance Unit (Staff and Activities), Where Applicable

Supervise the local pharmacovigilance team and promote pharmacovigilance standards throughout the organization.

Ensure that pharmacovigilance activities are adequately resourced.

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement.