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Associate Safety Director

Associate Safety Director

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Associate Safety Director

  • Location:

    Switzerland

  • Sector:

    Pharmacovigilance - Pharma

  • Contact:

    Denise Carroll

  • Salary:

    Negotiable

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04199_1674468503

  • Published:

    16 days ago

  • Startdate:

    ASAP

We are looking to hire an Associate Safety Director for one of our global Pharma clients based in Basel, Switzerland. The main responsibilities of this role are as follows:

· 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)
· Responsible for individual and aggregate case reporting activities including ICSR
case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
· Responsible for signal detection and management activities including, but not limited
to STAR maintenance, ISMP maintenance.
· Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
· Contribute to the development of the product safety strategy and provide drug safety
input into the Clinical Development strategy
· Contributing to risk management activities including preparation and maintenance of
CCDS, labelling document maintenance (including the IB), risk communications, RMP,
REMS
· Contributing to study management from a safety perspective through SMT/PET
activities and document review and maintenance across the development continuum
(Early phase to post marketing studies), including PASS
· Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorisation Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SPL
· 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.
· Author or contribute to scientific publications (abstracts, posters, papers) for scientific
meetings/journals
· Acts independently to manage safety responsibilities on study teams and in activities
supporting safety science
· Take on the responsibility for specialised roles with PCS. These may include, but are
not limited to; functional business process owner, subject matter expert.