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Combination Product Safety Medical Director -Remote (JP8209 )

Chicago, IL · Biotech/Pharmaceutical
Job Title: Combination Product Safety Medical Director -Remote (JP8209 )
Location: Virtual site- IL ,62706
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 2.4.21.
Note: Remote
3 Key Consulting is hiring a Combination Product Safety Medical Director -Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Fully remote role
  • Biotech/pharma/ biopharma/ medical device experience required.
Key Responsibilities
The Combination Product Safety worker 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 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
  • Clinical case assessment
  • Ability to assume multifunctional role in core Departmental activities
  • Scientific writing
  • MD or DO degree from an accredited medical school.
  • Doctorate degree and 2 years of directly related experience OR BSN OR RN With 8 YOE
  • Significant (3 years+) experience with combination products/pharmaceutical/biotechnology/device pharmacovigilance/risk management

Top Must have Skill Sets:
  • MD or OD
  • BSN OR RN With 8 YOE
  • Significant (3 years+) experience with combination products/pharmaceutical/biotechnology/device pharmacovigilance/risk management
Employee Value Proposition:
Actively engaged in regulatory reporting.
Red Flags:
Not looking for someone with only pharmacist credentials
Interview Process:
Phone screen
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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