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Combination Product Safety Medical Director

Thousand oaks, CA
The Combination Product Safety CW reports to the CPS Executive Medical Director and provides clinical advice in fulfilling its primary responsibilities:
Assess and provide strategic impact of potential safety impact of quality findings on patient/user safety for all clinical and commercial products in conjunction with members of the Global Safety Team and Product Quality
Review of adverse event data to detect potential product quality issues for commercial and development products
Provision of expertise for combination product safety data collection/analysis/reporting
Provision of expertise for combination product risk management activities
Combination Product Safety
Assists CPS staff and provides clinical expertise and strategic guidance in the assessment and management of combination product safety issues

Assists CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products

Ensures CPS staff reportability assessment activities and quality control takes place for device complaints/malfunctions (eg. Manufacture Incident Report).

Provides clinical insight into product quality medical evaluations including Health Hazard Assessments

Provides technical and clinical oversight to CPS staff in the authoring of combination product risk/benefit analyses

Provides clinical input in the development and maintenance of digital heath technology assets

Inspection Readiness
Undertakes activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
Key Competencies
Very strong knowledge of global regulatory requirements, standards, and guidances for pharmacovigilance/risk management in relation to combination products and standalone devices

Very strong understanding of device risk management methodology, tools, and terminology, including human factors engineering methodology
Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products

Strong understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes

"This posting is for Contingent Worker, not an FTE"

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