- a diverse job as Medical Safety Scientist in the pharmaceutical company
- an interesting job because of the international contacts
- a temporary contract for 1 year
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in Leiden (The Netherlands), but has a tight line all around the world. The organisation is looking for support for the pharmacovigilance department. Therefore they would like to meet an experienced and enthusiastic Medical Safety Scientist.
As Medical Safety Scientist you will work under the supervision of the Group Leader or Medical Director. You participate in or lead PV product responsible teams and participate in development core teams and core medical teams. Therefore you conduct ongoing monitoring and assessment of the safety profile of assigned developmental and marketed products. You will represent PV in the design, conduct, analysis and reporting of Phase 1 – Phase 3 and Post-Authorization Studies. You serve as the safety point of contact to other colleagues. Next to this you perform timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator’s Brochure and local product labeling. You also design safety surveillance strategies and manage safety signals for products. For the collection and identification of safety signals you use safety data for signal surveillance activities, categorization and prioritization. You collect them for authoring, medical review and approval of safety evaluation reports (SERs). You conduct risk management of assigned products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders. Futhermore you create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk. You also create, or assist in creating in PBRERs, DSURs and/of PADERs. But also on signal detection activities and create and/or review safety portions of submission documents. And last but not least you have the ability to participate in communications between business and safety to ensure appropriate safety context.
- a Bachelor’s degree in a scientific, health-related field
- at least 3 years of hands on PV experience in clinical and/or post marketing
- solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV
- hands on experience writing/reviewing Aggregate Reports , e.g., PBRERs, DSURs, and PADERs
- hands on experience with signal detection activities such as analyzing/categorizing/assessing data
- strong leadership skills
- excellent oral and written communication skills
- excellent listening and comprehension skills
- ability to work effectively in a matrix setting to resolve issues and achieve common goals
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/18-139-DD, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.