the 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
and clinical safety issues on behalf of the company.
- creates and manages an in-house and external Pharmacovigilance team.
- 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.
- responsible for the Pharmacovigilance-related Budgets.
- leading (interdisciplinary) projects as appropriate.
- acts as eu-qppv. it includes the following tasks in three domains:
1. the Pharmacovigilance system
it is the responsibility of the eu-qppv to oversee the good performance of the pv system. it includes maintenance of adequate pv procedures, proper performance of the Pharmacovigilance database, engagement of properly qualified staff in the pv system and having an complete overview of all pv contract and agreements.
2. overview of the safety and risk-benefit ratio of hal allergy products in Clinical Development and/or post-authorization and continuous Communication with regulatory authorities about any changes regarding this information following the guidelines for expedite reporting, preparation of periodic safety update reports (psur), Risk Management plans (rmp) and other relevant regulations and guidelines.
3. primary contact point for contact person
the eu-qppv is required to make him/herself available to the regulatory authorities 24 hours a day, 365 days of the year, without any exceptions as key
contact for any Pharmacovigilance inspections which a regulatory authority deems necessary.
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.
interested? we look forward to receiving your application (before 02/01/2019). to apply, please click the "apply" button below to the right where you will be prompted to upload your cv first.
hal allergy group is active in the field of Biopharmaceuticals
and is located at the bio science
park in leiden, the netherlands. our core business
is the development and Manufacturing
of therapies and Diagnostics
for allergic diseases. in addition, we offer contract Manufacturing
services via our CMO
named halix, fociusing on the production of biopharmaceutical products for (pre-) clinical studies. with offices in major european countries, hal allergy is one of the european top players in the allergy immunotherapy business
. established in 1959 hal allergy has long experience in developing, producing and Selling
allergy therapies with an immuno-modulatory effect causing a reduction in symptoms and long-term disease suppression. the allergy therapies are used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.
at our headquarters in leiden we currently employ more than 180 employees. at our locations in germany, poland, austria, spain and italy a further 100 persons are employed.
we are a growing and dynamic company with a culture that is strongly characterized by entrepreneurial spirit and a family atmosphere. this combination is the basis for an interesting and challenging environment.