- Region Basel
- Art des Vertrags Temporär - Vollzeit
- Tätigkeitssektor Chemie / Pharma / Biotechnologie
As a preferred supplier for Roche Basel, we are looking for an individual as
(contract for 18 months duration, with possible extension). The earliest start date is within 2 months. Home Office will be possible at the moment.
- 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
- 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
- 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 (e.g. 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
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.
- Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
- Veröffentlicht am 19. Mai 2022
- Berater-in Marijke van Engelenburg