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Clinical Safety Scientist

vor 2 Wochen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**_The Life Science Career Network_**

**Clinical Safety Scientist**

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.

We are currently looking for a** 6 months contract Clinical Safety Scientist.**

**Main Responsibilities**:

- 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)
- Signal detection and management activities such as STAR maintenance, ISMP maintenance.
- Provide expert contribution to the development of the product safety strategy
- Independent responsibility for risk management activities including preparation and maintenance of CCDS, labelling document maintenance (including IB), risk communications, RMP, REMS
- 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
- Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- Support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.

**Qualifications and Experience**:

- **Relevant Swiss working/residency permit or Swiss/EU-Citizenship required**;
- Minimum of 5-7 years of relevant experience in Safety/Pharmacovigilance
- Extensive knowledge of clinical trails and mature product safety
- Hands on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
- Ability to lead and influence in global matrix environments