Safety Officer en Multinacional Farmacéutica

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Safety Officer
Multinacional Farmacéutica
Barcelona, 19 May.
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Descripción
Multinational pharmaceutical company, headquartered in the industrial zone of Barcelona province looks for a Safety Officer to join the Pharmacovigilance team.

Reporting to the EU QPPV, will be responsible for:
• Maintenance of the Pharmacovigilance system Master File (PSMF) to ensure full compliance with all legal and regulatory requirements in the EU.
• Creation and update of Pharmacovigilance Standard Operating Procedures, SOPs, working instructions and templates of the Company.
• Creation and maintenance of a Pharmacovigilance Quality System/ Monitor compliance and ensure appropriate documentation (metrics, deviations).
• Preparation of Aggregate reports (PSURs, Addendum to the clinical overview), Risk Management Plans, Signal Detection Reports…
• Submission of PSURs through PSUR repository.
• Preparing / Performing Basic training of Pharmacovigilance for non PV employees.
• Monitoring scientific and medical literature for aggregate reports and signal detection.
• Signal detection company strategy/reports. EVDAS monitoring.
• Weekly global/local literature search including MLM, Eudravigilance, and National Authorities webpages if required.
• Unsolicited and solicited report management. Collection, database entry/coding QC/ follow-ups attempts and expedite reporting of ISCRs/SUSARs to EMA and other National Authorities if required.
• ADR follow-ups attempts, exchange with partners as per SDEAS.
• Cases reconciliation with partners as per SDEA.
• Regular collaboration with other PV team members at the affiliates and PV-services providers.

Numero de vacantes: 1
Tipo de contrato: Indefinido
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Requisitos
Requirements:
• Science degree.
• Proficiency knowledge on current European legislation is a must. Position of Certificate of EudraVigilance training on electronic reporting of ICSRs.
• At least 3 years Pharmacovigilance experience in pharmaceutical companies preferably at HQ Level or in a CRO.
• Expertise on Japanese and USA Pharmacovigilance legislation will be a plus.
• Experience on written Aggregate report, SOPs and RMPs. Proven experience on MedDRA coding and ICSR Data entry, QC… on vendors Pharmacovigilance databases
• Advance level of English.
• Advance use of Office package (word, excel, power point).
• Fast learner, Dynamic person, Detailed orientated, Flexibility, Strong Organisational skills

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
Ninguna



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