Combination Product Safety - Director role is needed for a CONTRACT opportunity for Yoh Scientific's client located in the Thousand Oaks, California area. This position is with the one of the world's largest independent biotechnology company. If you meet the requirements, please send your Word copy of your resume to Kelly.Hua@yoh.com.
Must Have the Following Experience:
1. Device safety and reporting experience
2. Risk management experience
3. EU MDR or global device regulatory
4. PV experience
To provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for products. The Combination Product Safety CW reports to the CPS Executive Medical Director and provides scientific advice in fulfilling its primary responsibilities:
• Assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products
• Review of adverse event data to detect potential product quality issues for commercial products
• Provision of expertise in Combination Product Safety (CPS) data collection / analysis / reporting in clinical trials, post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit / risk analyses
• 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
• Assists CPS staff and provides scientific 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 scientific insight into product quality medical evaluations including Health Hazard Assessments
• Provides technical and scientific oversight to CPS staff in the authoring of combination product risk/benefit analyses
• Provides scientific input in the development and maintenance of digital heath technology assets
• 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
• Very strong knowledge of global regulatory requirements, standards, and guidance 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
• Networking (cross functional)
• Relationship development and management
• Decision Making and prioritization
• Team work/collaboration
• Leadership and Management skills
• Regulatory interpretation
• Safety case assessment
• Ability to assume multifunctional role in core Departmental activities
• Scientific writing
• Doctorate degree and 2 years of directly related experience
• Master's degree and 6 years of directly related experience
• Bachelor's degree and 8 years of directly related experience
• Associate's degree and 10 years of directly related experience
• High School diploma / GED and 12 years of directly related experience
Opportunity is Calling, Apply Now!
Recruiter: Kelly Hua
What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
#ESNALS #ZipESDYoh Staffing. Keywords: Product Safety Manager, Location: Camarillo, CA - 93011