Full-Time Senior Pharmacovigilance Manager

Purpose: Primarily responsible for executing the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting, and resolution of PV audits. Ensuring alignment with RDQA policies and procedures and leading the development and implementation of the PVQA quality system. Providing advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.

Responsibilities:

• Assures quality and compliance in a regulated environment (worldwide and country-specific regulations, standards, and AbbVie policies).
• Evaluates PV processes through audit and QA oversight.
• Contributes to innovative quality strategies and solutions through collaboration with business partners.
• Contributes to development and continuous improvement of PV systems.
• Advances the AbbVie Quality System through systems and process development.
• Plans and executes PV audits, resolving non-compliance issues.
• Actively participates in PV inspections (onsite or remote) and supports resolution of findings.
• Promotes continuous education on PV regulations.
• Analyzes PV compliance data and emerging regulatory intelligence.

Qualifications:

• Bachelor's degree in science, health care profession, or equivalent experience.
• 5 years experience in biopharmaceutical industry or regulatory authority.
• 5 years experience in Quality Assurance and/or Pharmacovigilance.
• Strong analytical skills and organizational abilities.
• Understanding of quality systems and auditing standards.
• Knowledge of PV regulatory requirements and industry best practices.
• Flexibility, prioritization, project management, interpersonal, and communication skills.
• Ability to work independently and as part of a team.
• Willingness and ability to perform international travel (if required).

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