Manager, US Safety Governance - Pharmacovigilance
- Bachelor's degree
- Knowledge of pharmacovigilance processes and regulations.
- Proven track record of managing and delivering projects
- 5-10 years of relevant experience in either pharmacovigilance or quality and risk management
- Proven track record of managing and delivering projects particularly in the areas of Quality and Risk Management are preferred
- Collaborative working - Experience of working with teams and individuals in other parts of the business in a collaborative manner to develop business solutions and create value.
- Anticipate risks; think critically to get to the root of issues, challenge mindsets, and uncovers bias; interpret through patterns/data analysis and questions assumptions; decisive ability to take a stand even with incomplete information and amid diverse views; foster alignment through open and transparent dialogue, and effective stakeholder management
- Leading/Managing change - Designing and implementing change projects to improve business performance. Guiding a team through a period of change providing support and direction.
- Stakeholder management, internal or external - Managing multiple or particularly critical stakeholders, influencing the broader agenda outside of your business or organization.
- Highly motivated, hard worker, strong at working in and across teams, adept at identifying problems and developing creative solutions, ideation skills, conflict resolution.
- Experience in active leadership of projects/teams and ability to manage multiple projects well.
Manage US safety governance activities across the US GSK and ViiV business units (above business area activities).
- Authors and/or Manages safety related written standards and ensures efficient and effective utilization of these documents by stakeholder
- Maintain the local operating company Pharmacovigilance SOP; and training of the SOP
- Manages relevant safety process for the US business, to include but not limited to:
oUS Input into Central Safety authored reports
oConduct US Safety Data Exchange Agreement (SDEA) compliance checks and maintain SDEAs on the SDEA database and configuration on safety database
oManage dissemination of US DHCPL.
oManage the LOC Safety Training Plan
- Communicates safety related training recommendations to impacted groups
- Support air traffic control activities for safety related training
- Coordinate input into global training materials
- Support training delivery, as needed
Support US Safety Governance Lead and QRMs
- Project Management/Issue resolution/CAPA / Monitoring plans
Manages the US Safety Monitoring Measures, Metrics and Risk Register
- Ensure that the desired steps and processes are quality driven, compliant, monitored and documented
- Oversee Safety Management Monitoring plans across all business areas
- Manages safety compliance reports - works with the US Safety Governance Lead to define metrics
- Coordinate provision of US safety data for local and global reporting
Point of Contact for US safety related IBM assessments, internal audits, and Regulatory Agency inspections
- Support planning and strategy with internal audit teams
- Support assessment, audit, and inspection readiness activities
- Manages safety CAPA tracker and develops or coordinates CAPAs as needed
Support management of FDA PV Policy and Advocacy
- Coordinate input into FDA draft policy
- Project manage GSK implementation of new/revised FDA requirements
You may apply for this position online by selecting the Apply now button.
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