Safety Science Associate (Medical) Director
Our client is a pioneer in Drug Discovery and Development. As the world`s largest R&D spender in the pharmaceutical domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally. A leader in the field of manufacturing and selling of several drugs with treatment of Cancer.
We are currently looking for an enthusiastic Safety Science Associate Director or Safety Science Associate Medical Director for a contract to be based in Basel.
As an ideal candidate you should have 2+ years of experience in Drug Safety, Clinical Development or Medical Affairs within the pharmaceutical industry, and a solid understanding of GxP and regulated processes within clinical trial lifecycle, and ability to provide strategic input to senior management.
As a Safety Science Associate (Medical) Director you will be accountable for Safety-related deliverables for the product or program including the development and execution of the long-range safety strategic plans for the molecule, including the design, monitoring, analysis and reporting of studies and other data sources throughout the product lifecycle.
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action);
- Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans;
- Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication;
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician;
- Accountable for signal detection, evaluation and decision-making across the lifecycle of the product;
- Contribute to the ongoing Pharmacovigilance and Risk Management planning for designated products by preparation of the safety surveillance strategy;
- Contributes to the development and oversight of the signal detection plan and the signal detection and assessment activities;
- As assigned, support the Safety Science Leader or Director/Group Head, Safety Science or be responsible for the development of the RMP/ISMP or Risk Evaluation and Mitigation Strategies (REMS) for submission to regulatory health authorities (HA);
- Prepare and review periodic aggregate safety reports (Periodic Benefit Risk Evaluation Report/PBRER, Periodic Safety Update Report/PSUR, EU renewal and other Safety Reports) and benefit-risk assessments;
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information;
- Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests.
Qualifications and Experience:
- Degree in Life Sciences (PhD, PharmD) or MD;
- 2 or more years of experience in drug safety, clinical development or medical affairs within the pharmaceutical industry;
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance;
- Experience publishing in a refereed journal preferred;
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle;
- Strong orientation towards cross-functional teamwork;
- Effectively work with remote partners on a global team;
- Fluency in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.