Post Market Surveillance Specialist

Job Title Post Market Surveillance Specialist Job Description Job Title : Post Market Surveillance Specialist

Job 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
• In collaboration with stakeholders, defines standard risk acceptability criteria (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