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Associate Medical Safety Director
Temporary position for 12 months as an Associate Medical Safety Director at a pharmaceutical company
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 tight lines all around the world. The organisation is looking for support for the Pharmacovigilance department. They would like to come in contact with an experienced Associate Medical Safety Director.
De functie / The role
In de role of Associate Medical Safety Director you are responsible and accountable for the coordination and medical-scientific monitoring and assessment of the safety profile of one or more products. This position is expected to function autonomously, without a great deal of oversight from the Group Lead or (Medical) Director. Furthermore you lead GPV Product Responsible Teams for assigned products. You will also participate in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile. Next to that you are responsible and accountable for the timely identification and communication of emerging safety issues and updates of the Company Core Data Sheet, Investigator"s Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global Group Lead and with the applicable QPPV. Your are also responsible and accountable for the design of safety surveillance strategies, management of safety signals for products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Global Safety Science. Risk management of assigned products is also your responsibility 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 stakeholders, working closely with Global Safety Science. You also support the Global TA Group Lead, and, as appropriate (Medical) Director in the identification, development, implementation and communication of process improvements tools, systems and procedures within GMS to ensure efficiency and consistency in safety surveillance in the assigned Global TA and other Global TAs and Regional Teams within GMS, as well as on GPV level. You give support to the Global TA Group Lead, and, as appropriate (Medical) Director in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to the respective Global TA, ensuring feasibility and global alignment in collaboration with the GMS Leadership team.
Het profiel / Your profile
o at least a Master"s degree in Pharmacy or Medical (biology) as MD., D.O., PhD, or PharmD
o experience within the pharmaceutical industry in a relevant therapeutic area
o in-depth understanding of safety regulations for both marketed and investigational products,
and excellent knowledge of regional and global authority requirements, including ICH, and other
applicable requirements, able to influence decisions relating to patient safety and assessment
o demonstrated leadership capabilities in planning, allocating and managing multiple projects
o sound medical scientific knowledge to evaluate and interpret clinical and scientific data and to
communicate with both internal and external stakeholders
o specific working knowledge and experience in medical safety functions, including risk
o experience in working with databases Empirica, Argus and Litmon
o excellent communication and presentation skills in English (both written and spoken)
o strong interpersonal skills required with a demonstrated ability to handle conflict situations
o ability to deliver under pressure with limited resources
o ability to travel to meet the needs of the role
Het aanbod / The offer
o a diverse job at a pharmaceutical company
o an interesting job because of the international contacts
o a temporary contract for 12 months, with the possibility to extent
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-033-FMF, to Sandra van Putten: firstname.lastname@example.org. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.