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Safety Director

Safety Director

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Safety Director

  • Location:

    Switzerland

  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Denise Carroll

  • Salary:

    Competitive

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04207_1674468503

  • Published:

    15 days ago

  • Duration:

    12 months

  • Startdate:

    ASAP

A global pharmaceutical company based in Basel is seeking an experienced Safety Scientist to join their team for an initial 12-month contract. The main responsibilities for this role are as follows:

· 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, labelling 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 Authorisation 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