Einzelheiten
- Region Basel
- Art des Vertrags Temporär - Vollzeit
- Tätigkeitssektor Chemie / Pharma / Biotechnologie
Einführung
As a preferred supplier for Roche Basel, we are looking for an individual as
Safety Director
(contract for 1 year, with possible extension). The earliest start date is within 3 months. Remote/Home Office will be possible.
Aufgabenbeschreibung
- 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 specialized 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
- 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
- Enable/facilitate the transition of appropriate drug candidates from EMS to LMMS
Erforderliches Profil
- Qualified healthcare professional or Life Sciences graduate
- A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) would be advantageous
- 6 or more years of drug development experience in the pharmaceutical or related industry including at least 3 years in drug safety
- 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 in English
- 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
- Ability to effectively train others on departmental practices and processes
Application process
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. Please upload your CV in English or German along with your degree certificate and latest reference letter.
Informationen
- Agentur GLOBAL RECRUITMENT - +41 44 266 50 25
- Veröffentlicht am 18. Oktober 2022
- Berater-in Jie Zhu
