Overview:

Alphanumeric is seeking an experienced Pharmacovigilance Manager (Contractor) based in the United Kingdom, 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

Key Responsibilities:
• Provides oversight for all aspects of creation, maintenance, and archiving of written standards for 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 with PV Operations.
• Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
• Ensure that third parties/vendors develop and implement robust processes to support 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 ICSR. Management Director, where resolution is not possible or there is impact across PV Ops.
• Identify training requirements and work with training team to establish required training plan for individuals as required.
• Provide strategic advice to the ICSR Management Director team in regards to 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 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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