Brief Description:
The Senior Manager, Pharmacovigilance Compliance, Aggregate Safety Reporting and Labeling is responsible for executing PV Compliance activities based on relevant regulations, procedures, and contractual requirements. Through implementation of quality and compliance tracking tools/reports, oversight strategy and relationship management, this role will support the development and management continuous improvements across the pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of activities supporting the Medical Safety and Labeling sub-functions within GPV&L.
Essential Functions
- Define, develop, and deliver strategy for trending and reporting on aggregate safety report (ASR) quality reviews and health authority feedback
- Partner with the GPV&L sub-functions to enhance the ASR quality review process
- Perform quality review of ASRs and provide feedback to authors and leadership
- Collect, verify, and distribute metrics for monitoring compliance with signal management processes and timelines
- Support the development, implementation, and execution of Labeling quality and compliance KPIs/KQPIs
- Lead or support (as determined by line management) PV process improvements including authoring/updating controlled procedures as it relates to compliance activities
- Maintain documentation and reports for compliance continuous improvement activities
- Applies in-depth knowledge to effectively assist in inspection related activities, (pre-, peri- and post-inspection)
- Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support the patient safety at the local level
Required Knowledge, Skills, and Abilities
- Minimum 5+ years business, pharmaceutical, or biotechnology industry experience
- Strong Good Pharmacovigilance Practices (GVP) is required with specific knowledge of GVP Modules I, II, V, VII, IX
- Demonstrated ability to review complex documents and perform trending analysis
- Demonstrated ability to lead multi-disciplinary projects
- Excellent written and verbal communications skills
- Ability to work in an entrepreneurial and fast-paced culture
- Self-directed and ability to take action as needed with limited oversight
- Ability to influence or gain acceptance from others in sensitive situations
- Ability to collaborate and partner with various internal and external business partners.
- Ability to work in a team environment and support stakeholders
- Ability to work across geographical boundaries
- Disciplined, detail oriented, and strong time management skills
Required/Preferred Education and Licenses
- Bachelor's degree in business or life sciences required
- Lean Sigma certification, or equivalent certification, preferred but not required
