Governance Senior Manager providing leadership in managing complaints and legal matters for PFEW. Required expertise in employment law and governance principles, leading a team in a hybrid work environment.
About the role
- Director of Safety Data Operations and Governance supporting Electrophysiology business in healthcare innovations. Responsible for organizing and establishing governance structures for patient safety data sources.
Responsibilities
- Identify internal and external data sources relevant to patient safety, including but not limited to clinical trials, preclinical studies, and post-market surveillance.
- Secure access to these data sets in collaboration with cross-functional teams (R&D, Clinical, Regulatory, Quality, IT, Legal).
- Develop and implement a governance framework for data use within the EP Organization.
- Ensure compliance with data privacy, security, and regulatory standards.
- Maintain documentation of data sources, ownership, and usage guidelines.
- Partner with Medical Safety Officer, Medical Affairs, Clinical Operations, R&D, Quality, Epidemiology, and Data Science teams to integrate data for safety signal detection and risk assessment.
- Support development of dashboards and analytics tools to monitor patient safety trends.
- Act as a liaison between Medical Safety, Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, Quality, Legal and IT to ensure seamless data flow.
- Provide training and guidance on data governance best practices.
- Develop KPIs and metrics to measure data quality and governance effectiveness.
- Lead audits and compliance checks related to data governance.
- Support strategic initiatives for global harmonization of safety data standards.
Requirements
- Bachelor’s, Master’s or PhD degree in Life Sciences or related field.
- Experience in data governance, clinical data management, or pharmacovigilance.
- Strong understanding of regulatory requirements for clinical and post-market data.
- Expertise in integrating diverse data sources and leveraging analytics for safety and regulatory decision-making.
- Strong track record of cross-functional leadership and collaboration.
- Excellent communication and stakeholder management skills.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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