SENIOR DIRECTOR (QPPV)

Descripción de la oferta de empleo

The Senior Director, Qualified Person for Pharmacovigilance (QPPV), is responsible for providing the legal framework for pharmacovigilance of medicinal products for human use. In summary, the QPPV is responsible for establishing, maintaining, and managing the Marketing Authorisation Holder's (MAH's) pharmacovigilance (PhV) system, ensuring the PhV system is appropriately described in the PhV System Master File (PSMF), and having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the company holds marketing authorizations.

The QPPV:Serves as the Qualified Person responsible for Pharmacovigilance (QPPV), residing in the EU/European Economic Area (EEA), and fulfills the role of QPPV as defined in the current legislation and guidances;Acts as a single point of contact for PhV for the EU Competent Authorities and European Medicines Agency (EMA) on a 24/7 basis and also as contact point for PhV inspections;Maintains an overview of the safety profiles and emerging safety concerns of the company products with a marketing authorization application (MAA) or a marketing authorization (MA);Maintains oversight of the pharmacovigilance system applicable to products with an MAA or MA;Provides advice to Global Pharmacovigilance and Risk Management and to Regulatory Affairs with respect to Post Authorization Safety Studies (PASS) as required. Reviews and approves PASS protocols for studies conducted or pursuant to a risk management plan agreed; Maintains qualification for the position by attendance at suitable conferences and/or benchmarking with other pharmaceutical companies and/or attending meetings with regulators and/or working groups that monitor and influence legislation;Ensures oversight as required within the Global Pharmacovigilance and Risk Management organization to deliver full compliance.



Innovative work environment Excellent annual salary up to € 200000 gross Medical physician (M.D. or equivalent) with a minimum of five (5) years' experience in the pharmaceutical/biotechnology industry in pharmacovigilance/drug safetyIn-depth knowledge of Good Clinical Practice and Good Pharmacovigilance PracticeExcellent understanding of drug development and life-cycle management of medicinal productsExperience analyzing clinical case series for the purposes of aggregate safety reporting, signal detection, issue management, and responding to queries by regulatory authorities for both clinical and postmarketing productsExperience as an active contributor to EU submission dossier (Clinical Study Reports (CSRs), Clinical Overview, Renewal)Minimum of three (3) years of post-graduate clinical experience in academic or private practice including a hospital based setting, preferably in oncologyAdvanced knowledge of pre-and post-marketing US, EMA, and worldwide safety regulationsPrior experience as QPPV for a pharmaceutical or biotechnology company with active clinical research and developmentExperience in developing and executing risk management strategies (e.g., Risk Management Plans, risk minimization measures, monitoring of adverse events of special interests

Our client is a science-led biopharmaceutical company focused on the discovery, development and commercialization of medicines in oncology and other disease areas. There is a firm belief that investments in innovation create value. This company has a strong collaborative network with academic and pharma partners all over the world to advance drug development and improve the lives of patients.

pExcellent salary up to € 200000 gross per year to be determined based on skills;Great secondary benefits;One year contract with the intention for extension to an indefinite contract;Innovative work environment. For one of our top clients we are recruiting for a Senior Director, Qualified Person for Pharmacovigilance (QPPV). We are looking for a candidate who has a strong analytical mind and an eye for detail. Are you flexible, accurate and do you have good planning skills? Then we might be looking for you!

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Detalles de la oferta

Empresa
  • Sin especificar
Localidad
  • Sin especificar - Sin especificar - ES
Salario
  • 140000€
Fecha de publicación
  • 19/10/2018
Fecha de expiración
  • 21/03/2019