Overview:
Alphanumeric is seeking an experienced
Pharmacovigilance Manager
(100% remote) based in the UK for project-based contract work. This project is for one of the biggest pharmaceutical brands in the world. Job Purpose: The key purpose of this role is to support Pharmacovigilance Operations (PV Ops) - ICSR Management. Job Conditions: Start date: December 2nd, 2024. Type of contract: 13-month temporary contract (with possibility of extension). Location: 100% remote in the UK as per client request. The leadership team is based in London. Working shift: business hours in London - some flexibility is well appreciated thanks to the global nature of our company. Competitive salary. Key Responsibilities: Provides oversight for all aspects of creation, maintenance, and archiving of written standards for the ICSR Management Team. Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements; where problems or issues are identified, assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs). Escalate identified problems or issues to the appropriate Management Personnel within PV Operations. Generate new ideas and proposals for global implementation; contribute to the advancement of PV Operations methodology and processes. Ensure that third parties/vendors develop and implement robust processes to support a quality-driven organization and in agreement with ICSR Management Team written standards. Build external relationships with key stakeholders and senior leaders. Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations, adherence to the client's SOPs, and all ICSR Management Team written standards. Resolve issues and concerns within the ICSR Management team and escalate to the ICSR Management Director where resolution is not possible or there is an impact across PV Ops. Identify training requirements and work with the training team to establish the required training plan for individuals as needed. Provide strategic advice to the ICSR Management Director team regarding written standards, processes, and procedures. Mentor new staff during onboarding. Use influencing skills to drive best practice and innovation across PV Ops. Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub-teams. Education Requirements: Degree in life sciences or a medically related field or previous experience equating to educational requirements. Job Related Experience: Process development and maintenance of written standards, e.g., SOPs, Work Instructions, Job Aids, How-To Guides, etc. Ability to map processes and author written standards. Knowledge and experience with pharmacovigilance systems.
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Pharmacovigilance Manager
(100% remote) based in the UK for project-based contract work. This project is for one of the biggest pharmaceutical brands in the world. Job Purpose: The key purpose of this role is to support Pharmacovigilance Operations (PV Ops) - ICSR Management. Job Conditions: Start date: December 2nd, 2024. Type of contract: 13-month temporary contract (with possibility of extension). Location: 100% remote in the UK as per client request. The leadership team is based in London. Working shift: business hours in London - some flexibility is well appreciated thanks to the global nature of our company. Competitive salary. Key Responsibilities: Provides oversight for all aspects of creation, maintenance, and archiving of written standards for the ICSR Management Team. Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements; where problems or issues are identified, assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs). Escalate identified problems or issues to the appropriate Management Personnel within PV Operations. Generate new ideas and proposals for global implementation; contribute to the advancement of PV Operations methodology and processes. Ensure that third parties/vendors develop and implement robust processes to support a quality-driven organization and in agreement with ICSR Management Team written standards. Build external relationships with key stakeholders and senior leaders. Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations, adherence to the client's SOPs, and all ICSR Management Team written standards. Resolve issues and concerns within the ICSR Management team and escalate to the ICSR Management Director where resolution is not possible or there is an impact across PV Ops. Identify training requirements and work with the training team to establish the required training plan for individuals as needed. Provide strategic advice to the ICSR Management Director team regarding written standards, processes, and procedures. Mentor new staff during onboarding. Use influencing skills to drive best practice and innovation across PV Ops. Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub-teams. Education Requirements: Degree in life sciences or a medically related field or previous experience equating to educational requirements. Job Related Experience: Process development and maintenance of written standards, e.g., SOPs, Work Instructions, Job Aids, How-To Guides, etc. Ability to map processes and author written standards. Knowledge and experience with pharmacovigilance systems.
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