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Safety Scientist II

Safety Scientist II

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Safety Scientist II

  • Location:

    United States Virgin Island

  • Sector:

    Pharmacovigilance - Medical Device

  • Contact:

    Denise Carroll

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04053_1663659927

  • Published:

    12 days ago

  • Duration:

    12 months

  • Startdate:

    ASAP

MSI Pharma are working with a globally recognised pharma company to help source a Senior Safety Scientist. The client is looking for someone with at significant safety signal experience, aggregate report writing and risk management experience.

Description:

* Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas

* 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. 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

* Contributing to risk management activities including preparation and maintenance of CCDS, labelling document maintenance, risk communications, RMP, REMS

* Contributing to study management from a safety perspective through SMT/PET and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS

* Acts independently to manage safety responsibilities on study teams and in activities supporting safety science

* Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL and PCS Team Lead

* Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable Preferred Qualifications:

* A relevant postgraduate qualification (e.g., PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous

* Safety scientist (level 2): 2 or more years of drug safety, clinical development, or medical affairs experience in the pharmaceutical or related industry