Safety Scientist

For our customer located in Basel/Switzerland we are currently looking for a**:Safety Scientist **(M/F/d)**

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To support internal team movements, we are looking for 3 Clinical Safety Scientist to join the group and hit the ground running. We need senior profile able to be independent, without extensive training. This is why we are looking for someone with a minimum of 5 to 7 years of relevant experience in Safety (DSR, CSR, IB, DSUR, etc.) and with a Life Science education background.

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General Information: *
- Start date: ASAP
- End date: 18 months duration (Extension: to be discussed)
- Remote/Home Office: home office at the moment

**Tasks & Responsibilities**
- 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)
- Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance.Contribute to the review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
- Provide expert contribution to the development of the product safety strategy
- Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling 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
- In partnership with the SSL, 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.
- May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
- Responsible for coordination and collaboration with vendors servicing Safety Science

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Additional responsibilities, under the delegated accountability of the SSL: *
- Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents (e.g., IDCP, CDP)
- Accountable for the safety components of study reports, aggregate reports and high level regulatory documents
- Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
- Lead the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective

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Behaviours and responsibilities*
- Demonstrates behaviors consistent with our clients values and engenders confidence from senior management
- Understands how safety activities contribute to company development and commercialisation goals and takes measures to maximize safety value to the organization
- Demonstrates independence and high competence in the conduct of all safety science responsibilities
- Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams
- Consistently comply with all governing laws, regulations, QMS, our clients standard operating procedures (SOPs) and other guidelines
- Develop and maintain knowledge of the pharmaceutical industry and drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements Acts independently and with mínimal supervision to manage safety responsibilities on study teams and in activities supporting safety science
- Trains and mentors more junior PCS scientists
- Proactively takes on responsibility for complex deliverables
- Takes on team leadership responsibility in order to manage and complete medium and high priority projects
- Seen by peers and cross-functional colleagues as an expert in many safety science activities
- Contributes to embedding the agreed organizational models, and the necessary mindsets
- Leading self and others, often influencing without authority, to deliver outcomes.
- Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
- Willing to challenge embedded behaviors/mindsets, in order to bring new and agile approaches to ways of working, and/or to improve quality and efficiency.