Associate Safety Director (m/f/d) — Coopers Group AG
NewCHF 85'500 - 129'500
Coopers Group AG · Basel-Stadt (BS)
- Location
- Basel-Stadt
- Contract
- contracting
- Posted
- 3 days ago
SalaryCHF 85'500 - 129'500
Role overview
Your Tasks
Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.
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).
- Your Tasks:
- Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.
- Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
- Take on the responsibility for specialised roles with PCS.
- Life Sciences - Clinical & Safety Basel-Stadt Contracting Full Time
- ASAP (latest 21.08.2026) - 01.08.2027
Main responsibilities
- Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.
- Take on the responsibility for specialised roles with PCS.
- These may include, but are not limited to; functional business process owner, subject matter expert.
- 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 Your Profile: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline;
- PharmD or other post-graduate health professional qualifications) would be advantageous.
- 4 or more years of drug development experience in the pharmaceutical or related industry.
- At least 3 years in drug safety/PV or a closely related field.
Key requirements
- Life Sciences - Clinical & Safety Basel-Stadt Contracting Full Time
- ASAP (latest 21.08.2026) - 01.08.2027
- pharmacovigilance, Drug safety, Signal detection, Clinical Operations
Application process
- IT/Tool Skills good excel/word/powerpoint skills; able to extract data from the Safety Database and apply complex data analysis
- 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.
Additional details
- These may include, but are not limited to; functional business process owner, subject matter expert, safety committee Your Profile: A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline;
Notes and original content
- These may include, but are not limited to; functional business process owner, subject matter expert, safety committee Your Profile:
- A relevant postgraduate qualification (e.g.
- PHD/MSc in a Life sciences discipline;
