Luogo di lavoro:Roma
Nome filiale:MOC - ROMA
Numero di candidati ricercati:1
Azienda: Il nostro Cliente è un'Azienda Leader operante nel settore Chimico/Farmaceutico.
1 Pharmacovigilance Associate.
Mission: Is expected to be able to learn the required core pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures.
Under the supervision of the Head of Country PV and/or the Senior PV Associate, the PV Associate Jr is responsible for performing some of the required local market core PV activities.
Key responsibilities and major duties:
1. Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases
2. Submission of single cases to local Health Agencies(HA) and Ethics Committees
3. Provision of safety information.
4. Implementation of Pharmacovigilance Agreements
5. Maintenance of PV Awareness and Training
6. Ensure PV Audit and Inspection Readiness.
7. Planning, processing and reporting of Aggregate Reports to HA and EC.
8. Local Market Safety Data Quality Control.
9. Risk management plans.
'' Ideally, some experience of working in a medical environment or a reasoned desire to gain experience in PV.Experience in pharmacovigilance and clinical trial-related issues.
'' University degree (preferably life science) or nursing qualification.
'' Ability to deliver quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally. Understands relationships within GPVE & externally.
'' Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups and relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company).
'' Possess good interpersonal, verbal, and written communication skills. Able to learn the skills required to research, compile and provide safety information in a clear concise manner to the local team.
'' Ability to develop a good understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for Pharmacovigilance.
'' Develops an awareness of the safety profile and any emerging PV issues with BMS products (marketed or investigational ) in the local affiliate.
'' Develops the ability to review safety information with attention to detail and accuracy in verification of source data and related safety documentation/records. Able to prioritize multiple tasks to meet deadlines, effectively solve PV issues and utilizing effective problem-solving approaches with guidance from supervisor. Ability to comply with relevant internal and external processes/guidelines/regulations. background.
'' Capable of using Microsoft Suite, Safety database, other systems as needed (procedural documents, training, etc.) Microsoft Suite, Safety database, other systems as needed (procedural documents, training, etc.).
'' Increase pharmacovigilance experience.
'' Exposure to local and regional management.
'' Involvement in projects.
Si offre un contratto di somm.ne di 6 mesi. Livello d'inquadramento commisurato all'esperienza. Luogo di lavoro: Roma Eur
Manpower è una compagnia eticamente responsabile. Il servizio è gratuito. I candidati ambosessi (L.903/77 - D.Lgs. n.198/2006) sono invitati a leggere l'informativa Privacy su www.manpower.it Aut. Min. Prot. N. 1116 - SG - del 26/11/04.
Il titolare della registrazione e/o candidatura dichiara di essere a conoscenza delle sanzioni penali previste in caso di dichiarazioni mendaci o contenenti dati non più rispondenti a verità come previsto dal D.P.R. nº445 del 28.12.2000
Codice annuncio: NT0016888A