Senior Director (QPPV)
Innovative work environment
Excellent annual salary up to € 200000 gross
Om vår klient
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.
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.
- 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.
Vem söker vi?
- Medical physician (M.D. or equivalent) with a minimum of five (5) years' experience in the pharmaceutical/biotechnology industry in pharmacovigilance/drug safety
- In-depth knowledge of Good Clinical Practice and Good Pharmacovigilance Practice
- Excellent understanding of drug development and life-cycle management of medicinal products
- Experience 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 products
- Experience 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 oncology
- Advanced knowledge of pre-and post-marketing US, EMA, and worldwide safety regulations
- Prior experience as QPPV for a pharmaceutical or biotechnology company with active clinical research and development
- Experience in developing and executing risk management strategies (e.g., Risk Management Plans, risk minimization measures, monitoring of adverse events of special interests
- 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.