ROLES AND RESPONSIBILITIES :

Post Market Surveillance (PMS) :

- Ensures standard PMS processes across business units

- Assures consistent PMS plans exists for all products

- Assures consistent and standard process exists to perform proactive surveillance (e.g. regulatory database searches, literature reviews) and reactive surveillance (e.g. complaints handling, field actions)

- Assures consistent PMS Reports across business units

Patient Safety and Regulatory Reporting :

- In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions

- Assesses product relationship to reported complaint.

- Assures standard regulatory reporting assessment criteria

- Provides input to clinical conclusion to be included in the reports to competent authorities

Risk Management :

- Support standard RM processes across DI

- In collaboration with stakeholders, defines standard RAC with stakeholders

- Supports the development of consistent RM plans exists for all products

- Assures consistent RM plans exists for all products

- Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations

PMS and RM Governance :

- Assures standard PMS and RM governance across Business Units

- Provides oversight of PMS and RM processes and assures standard approach across DI

- Signal Assessment & Escalation :

a. Ensures standard statistical trending techniques

b. Assesses significant triggers & safety concerns.

c. Manage recurrent PMS/RM data review meetings

d. Assures standard approach for signal disposition

e, Incorporate findings in PMS reports and updated RM files as required

PMS and RM input into Product Development :

- Represent PMS interests in multi-disciplinary teams during product development.

- Assures development and completion of PMS & RM deliverables throughout the design process

- Provides input of PMS related product risk & quality issues during the development of new products

REQUIRED EXPERIENCE :

- Bachelor's degree in health science or similar healthcare-related field, such as Medical Doctor MD, Nursing, Radiology, Registered Pharmacist (RPH), or equivalent (4 year degree required; additional education is desirable)

- 15+ yrs of Industry experience

- 6 to 8 years of experience in the pharmaceutical / medical device industry or direct device clinical experience

- Experience supervising others is desirable

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES :

- Demonstrates collaborative patient and customer focus

- Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices

- Must have direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred.

- Experience interacting with the FDA, ISO, and Other Regulatory Authorities

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