(Deputy) Head of Pharmacovigilance at HAL Allergy
The (deputy) Head of Pharmacovigilance is responsible for:
- the establishment and maintenance of the pharmacovigilance system in full compliance with the European regulations,
- having insight into the risk-benefit profiles and clear overview of any emerging safety concern with HAL Allergy products;
- serving a contact point for regulatory authorities for pharmacovigilance and clinical safety issues on behalf of the company.
- Co-creates and manages an in-house and external pharmacovigilance team.
- Co-responsible for the growth and adaptation of the pharmacovigilance department to meet the needs of the company.
- Responsible to ensure the development and execution of safety education and training of employees and vendors.
- Responsible for the performance of post-approval surveillance studies
- Implements policies, systems and a culture to ensure ongoing compliance of pharmacovigilance requirements.
- Co-responsible for the pharmacovigilance-related budgets.
- Leading (interdisciplinary) projects as appropriate.
- Act as Head of Pharmacovigilance in the absence of the Head.
- Acts as EU-QPPV, in absence of the Head.
- Medical Degree or advanced degree in health care with similar experience meeting the requirements to act as EU-QPPV in the EU;
- At least 5 year pharmacovigilance/drug safety experience in the pharmaceutical/health care industry both in clinical development and post approval period;
- Expert knowledge of pharmaceutical regulations, standards, current industry practices and strong experience with interpretation and application;.
Personal & Professional Skills:
- Hands-on mentality and flexibility to act in an heavily regulated environment.
- Meeting established schedules and resolving technical and operational challenges in a matrix environment.
- Ability to manage and build a team, and relationships with other colleagues and external experts.
- Excellent written and oral communication and presentation skills.
- Punctual, accurate and precise way of working.
- Wide experience in PV-specific databases.
- Basic knowledge of epidemiology & pharmaco-epidemiology methods and biostatistical analysis.
- Implementation of regulations in day to day practice.
- Ability to identify risks, and make decisions independently and escalate issues when necessary.
- Confident, pro-active, team spirit and the ability to work under time pressure.
- Fluent in English, both oral and written. German basic language skills or willingness to learn German language.
- Good MS-Office skills.
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases. These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies. HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people across various roles. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.