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Global Safety Officer I&I

Global Safety Officer I&I

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Global Safety Officer I&I

  • Location:

    United States Virgin Island

  • Sector:

    Pharmacovigilance - Medical Device

  • Contact:

    Denise Carroll

  • Salary:

    US$220000 - US$270000 per annum + full corporate package

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/03979_1655477137

  • Published:

    16 days ago

  • Startdate:

    ASAP

MSI Pharma are working with a globally recognised pharma company to help source a Senior Level Safety Physician to work on their blockbuster drug. The client is looking for someone with at significant global safety experience, a strong academic record and clinical medicine experience in an advanced medical setting.

To be considered for this position, you must have:

· Medical Degree (MD or MBBS)
· Experience working in clinical development safety
· Experience leading signal detection and risk management activities
· Experience working in hospital/clinical medicine
· Right to work in the USA

In this role, you will be responsible for:

· You will be the safety expert for product
· Supporting signal detection and risk management activities on the assigned drug.
· Leading cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs).
· Communicating with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
· Providing strategic and proactive safety input into development plans.
· Identifying and implement proactive safety analysis strategies to further define the safety profile.
· Leading aggregate safety data review activities and coordinating safety surveillance activities.
· Co-leading benefit-risk assessment with other relevant functions.
· Developing risk management strategies and plans and monitor effectiveness.
· Representing safety position in cross functional submission teams.
· Ensuring generation, consistency, and quality of safety sections in submission documents.
· Writing responses or contributions to health authorities questions.
· Documenting, coordinating, reviewing and validating Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.



In this role, you will be responsible for:

· You will be the safety expert for product
· Supporting signal detection and risk management activities on the assigned drug.
· Leading cross functional Safety Management Teams (SMTs) and GPE internal Safety Analysis Teams (SATs).
· Communicating with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
· Providing strategic and proactive safety input into development plans.
· Identifying and implement proactive safety analysis strategies to further define the safety profile.
· Leading aggregate safety data review activities and coordinating safety surveillance activities.
· Co-leading benefit-risk assessment with other relevant functions.
· Developing risk management strategies and plans and monitor effectiveness.
· Representing safety position in cross functional submission teams.
· Ensuring generation, consistency, and quality of safety sections in submission documents.
· Writing responses or contributions to health authorities questions.
· Documenting, coordinating, reviewing and validating Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report.