Global Medical Safety Scientist
Date Posted: Tuesday, 31st of January 2012
Salary: £80,000 - £100,000
Start Date: Negotiable
Telephone: 01438 743 047
Location: South
Consultant Name: Moin Din
Sector: Pharmaceutical
Description
Description:
The Global Medical Safety Physician will report to and assist the GMS Therapeutic Area (TA) Head in the safety assessment of assigned drugs within the TA that are marketed and/or in clinical development. The GMS Physician willhelp ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the TA. The GMS Physician will help ensure communication of potential and known risks, when appropriate, to theTA Safety Head, Chief Safety Officer (CSO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients.
Principal Responsibilities:
Provide medical expertise to^the GMS TA and provide medical oversight to non-physician GMS staff including:
Defining the safety question or issue requiring medical safety assessment
Developing the strategy for the safety review and analysis
Interpreting results and determining the medical importance of question or issue
Reviewing and approving (i.e., signatory) for medical assessment reports, e.g. ad hoc safety reports
Provide end-to-end (Phase 1 through product life cycle) safety support and surveillance
^Chair a multidisciplinary Safety Management Teams for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities (including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)), as well as other activities related to managing the safety profile of assigned products.
Participate in HA interactions regarding safety and risk management, both written and verbal.
Education and Experience:
Demonstrated skills in clinical medicine and/or Pharmacovigilance.
Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessmentof drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations.
Ability to influence, negotiate and communicate with both internal and external customers.
Required Technical Knowledge and Skills:
Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions^to regulatory filings, PV documents and risk management plans.
Able to plan work to meet deadlines and effectively handle multiple priorities.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meetour selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23601 in all correspondence.
