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Affiliate Support Manager EMEA
Temporary position to support the DSO`s at the affilates
Het bedrijf / The company
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 The Netherlands. The European organisation is located in Leiden but has a tight line all around the world. The organisation is looking for support for the Pharmacovigilance department. They would like to come in contact with an experienced and enthusiastic Affiliate Support Manager.
De functie / The role
As Affiliate Support Manager you interact with the Drug Safety Officer and affiliate staff to ensure audit and inspection readiness and develop, oversee and implement associated CAPAs. You support affiliates in development and execution of inspection and audit CAPAs. You develop regional Drug Safety Officer SOPs and review local SOPs for consistency with regional/global regulatory requirements, SOPs and organisation expectations. You ensure delivery of training to Drug Safety Officers in consultation with the DSP Training Manager. Monitoring Drug Safety Officer performance based on predefined KPI is also your responsibility. You initiate and manage process improvement projects related to affiliate procedures. You ensure training requirements for DSOs are kept up to date and interact with DSO and other affiliate staff for implentation of PV-related regional and/or global procedures. In the role you communicate with different stakeholders. Your portfolio is around 25 Drug Safety Officers located at the affiliate. You report to the head of DSO Management.
Het profiel / Your profile
o minimum B.Sc. degree in Life Sciences
o indept knowlegde of regulatory requirements
o technical expert or manager with an in-depth understanding of all aspects of pharmacovigilance and related disciplines
o experience in leading a team, project or process function
o a strong cultural sensitivity, influencing skills without direct hierarchy
o good oral and written communication and presentation skills in English
o willingness to travel up to 50%
Het aanbod / The offer
o a diverse job in Pharmacovigilance at a pharmaceutical company
o an interesting job because of the international contacts
o a temporary contract for 9 months, with the possibility to extent
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-030-FMF, 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.