(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.