Responsible Pharmacovigilance position – Specialist in Pharmaceutical Affairs (RA/QA)
- Linking pin between global and local departments
- Variety in responsibility and tasks
- Opportunity to construct own policy and structure for PV operations
Our client, family owned, is an innovative and global active pharmaceutical organization, however with their main activities within the European region. Their main focus is development and marketing of pharmaceutical products in the area of lung diseases. Our clients’ mission is to create the best possible quality of life for every patient with the right combination of active pharmaceutical ingredients. Their core values are entrepreneurship, innovation, team spirit and integrity. They take responsibility for their Research and Development. They are active in the Netherlands for more than ten years, with 70 employees in their office in the Randstad Area. Together they are working for the medical, marketing and sales activities. Due to the growth of the affiliate and the amount of products and activities, they have created a new role within the company: Head of Pharmaceutical Affairs.
In this position you will be responsible for all Pharmaceutical Affairs: PV, local regulatory affairs (RA), local QA and Medical Information. The largest part of your time and responsibility will go to the pharmacovigilance (PV) processes in the organization. As the Head of Pharmaceutical Affairs you work on all aspects that are involved with PV and drug safety. Therefore, you will be responsible for the operational tasks as well as strategic and governance matters regarding PV. These activities include, but are not limited to, collecting and controlling of reports of side-effects, signal detection, writing of Risk Management Plans and Periodic Safety Update Reports (mostly in cooperation with Corporate PV functions). The entire PV spectrum of work is thus represented in this role. From reporting side-effects to advising the Management team on the best governance for PV (and RA).
Besides this, you keep the PV system up-to-date with international guidelines and restrictions and report the information to the authorities as needed. Because of the great variety in the responsibilities you need to have affinity with Regulatory Affairs and Quality Assurance too. You will be working closely with the global department for pharmacovigilance and drug safety within the global organization. There is also a close collaboration in Regulatory Affairs between the German affiliate of Chiesi (Hamburg) and the Dutch affiliate. You report to the Medical Director.
- M.Sc. degree in life sciences; preferably Pharmacist
- At least three years of experience in PV within a pharmaceutical organization
- Experience with (inter)national guidelines and restrictions for PV
- Experience with Regulatory Affairs; preferably also with QA principles
- Accurate, decisive, thorough, team player, autonomous, self-sufficient, creative
- Excellent communication, interpersonal and social skills
- Fluent in Dutch and English, verbal and written
- Able to travel abroad for work
Interested? Please send your resume and motivational letter by Email, with reference to WL/17-084-DD: firstname.lastname@example.org.
For further information, please call Tessa Hoedjes at number +31 (0)33 472 80 87.
Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.