Pharmaliaisons is working with an innovative biotech company that has its global headquarters based in Basel. The company has a multiple of products in nervous system disorders, cardiovascular diseases, immunological disorders, and orphan diseases, with some products approved in the market and some in clinical trials. The company is looking for an Associate Director Safety Scientist who will be the Safety Lead on multiple products, chairing activities such as signal detection, aggregate reports, and risk management planning. Please see an overview:
* Leads and manages generation of Risk Management Plans (RMPs), Signal Detection Reports, and safety assessment reports.
* Serves as Project Management for Signal Management and Safety Management Team and ensures adherence to project timeline.
* Acts as the safety signal tracking and management lead ensuring that new safety signals identified are properly tracked and documented ensuring oversight on the signal activities and timely completion of safety measures or actions as determined.
* Acts as the lead author in close cooperation with the responsible Drug Safety Physician in the medical writing of periodic safety reports or other ad-hoc safety analysis reports.
* Works with Medical Safety Head to support regulatory submissions (PSURs, RMPs) and develops the strategy for risk minimization activities for post-marketing.
This is a senior role that will report directly to the Global Safety Head. The company has a hybrid working policy and is based in Basel. Please reach out if you could be interested in the position, and someone from the team will be in touch.
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