Medical Safety Director
Venaris Executive Search ApS
Pharmacosmos
Medical Safety Director
About the job Medical Safety Director
Join Pharmacosmos as they embark on their next growth phase in an exciting safety surveillance position, being at the forefront of monitoring, evaluating, and ensuring the safety of Pharmacosmos's products
Uphold safety standards through strategic and operational initiatives
Reporting directly to, VP Global Drug Safety, you will step into a senior specialist role (Director level) with a wide range of operational and strategic tasks and responsibilities that offers broad responsibility, significant influence, and high independence.
Your primary responsibility will be to secure all safety aspects of clinical development, ensuring timely and appropriate resolution of safety issues as well as guaranteeing strict adherence to regulatory guidelines and internal protocols, preparing meticulously for- and participating actively in audits and inspections. As such, you will act as Global Medical Safety Monitor in ongoing clinical trials and you will become responsible for providing safety input to a wide variety of strategic safety related materials and documents.
Additionally, you will engage actively in multidisciplinary Clinical Trial teams, holding membership for assigned drug safety. You will interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities and serve as the primary point of contact for safety-related matters across various departments.
Finally, you will to a lesser degree become involved in post marketing activities where you engage in continuous surveillance activities, including signal detection and evaluation, develop and prepare risk management plans, preparation of aggregated reports and medical evaluation of Individual Case Safety Reports (ICRSs).
Senior Safety Surveillance profile with Clinical Development experience
For this position, it is expected that you hold a relevant scientific masters degree from the life science field, combined with extensive experience in drug safety/pharmacovigilance covering both clinical development and post-marketing within the pharmaceutical industry. This has provided you with a solid understanding of clinical development and strong experience with worldwide regulatory authorities interactions. Furthermore, it is crucial that you possess excellent interpersonal skills, enabling you to communicate effectively at all levels paired with the natural ability and authority to engage and motivate people. Lastly, you are fluent in Danish and English, both written and spoken.
Personally, you are proactive, pragmatic, action-oriented, and decisive. Collaborating with different people at all levels in an organization comes naturally to you, and you thrive in a position where you constantly are aiming for excellence. Additionally, you have a strong quality mindset, and you have a proactive and solution-oriented approach, and you are not afraid to grapple with the unknown and be innovative. Finally, you enjoy working in an organization with a dynamic pace and a broad range of tasks and responsibilities, requiring you to balance risk and value to ensure safety.
Unlock innovation and accelerate growth with Pharmacosmos
This is your chance to embark on an exciting journey with Pharmacosmos, as they continue to seize strategic opportunities, driven by a strong ambition to benefit more patients globally and address unmet medical needs. The recruitment process is carried out by Venaris Executive Search. For more information regarding the position, please reach out Sr. Executive Search Consultant, Lars Nordlund Bidstrup, on +45 3123 3018. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV - it is not necessary to include a cover letter.
Pharmacosmos
Founded in 1965, Pharmacosmos is a global healthcare pioneer in carbohydrate chemistry and a leader in the development of innovative treatments for blood diseases, including iron deficiency anemia and cryopreservation technology. On September 18th, 2024, Pharmacosmos announced the successful completion of their acquisition of G1 Therapeutics, a commercial-stage oncology company. The acquisition aligns perfectly with Pharmacosmos' strategy by leveraging their extensive expertise in blood diseases, positioning the company for its next phase of growth and strengthening its global commercial portfolio. Headquartered in Holbæk, Denmark, Pharmacosmos employs 650 dedicated employees, with products marketed in over 40 countries worldwide. Please also visit www.pharmacosmos.com
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