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Clinical Safety Scientist

ITech Consult

Posted on Apr 8, 2022 by ITech Consult

Basel, Switzerland
Health Care
1 May 2022
Annual Salary

Clinical Safety Scientist - Pharmacovigilance/ DSR/ GVP / clinical trial/ products safety

Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership or SSLs (Safety Strategy Program Leaders) depending on the deliverable/activity.

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 (eg, 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
- Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.)
- 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.
- Perform specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert, safety committee member.
- Responsible for coordination and collaboration with vendors servicing Safety Science

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 life cycle strategic planning documents (eg, 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
- Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS

Behaviours and responsibilities
- Demonstrates behaviors consistent with Roche values and engenders confidence from senior management
- Actively emulate and role model the Roche values, culture (mindset and behavior), Roche core competencies and PD/PDS strategy and drive for similar performance across relevant team
- 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

Must Haves:
- Education in Life Sciences
- Minimum 5 to 7 years of relevant hands on experience in Safety/Pharmacovigilance
- Hands on experience with clinical trial and mature products safety
- Hands on working experience with Risk Management Plan, Protocols, DSR, DSUR, CSR, IB, Adverse Events, etc.
- The ability to demonstrate a broad understanding of the scientific aspects of safety, PV and clinical/patient risk management (eg via demonstrable knowledge of the application of GVP, GCP & CTR requirements) is essential.
- Demonstrated ability to lead and influence, with and without authority, in a global Matrix environment.
- Excellent written and verbal communication skills.
- Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
- Evidence of proactive, structured thinking with the ability to rapidly respond to an evolving and complex environment.
- Apply complex data analysis/statistical methods to evaluate, interpret and present scientific data with clarity
- Strong presentation skills, effective at summarizing and presenting the key considerations and decision points

Reference: 1558907905

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