Director, Global Pharmacovigilance Quality

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job Summary:

The Director, Pharmacovigilance (PV) Quality is responsible for leading compliance and quality assurance Post-Marketing PV, Clinical PV, and related services across all ProPharma locations worldwide. The Director will ensure that quality activities are performed in accordance with corporate policies, guidelines, regulatory requirements, and other applicable standards internationally.  This position is responsible for the following:

• Ensure that quality systems are in place and integrated across all ProPharma locations where PV activities are performed.
• Ensure that PV services provided by ProPharma are appropriately monitored and assessed for quality.
• Manage, develop, and support the team of Quality Assurance professionals with PV quality responsibilities in each region to ensure that they have the necessary skills to ensure that the Company’s quality programs are effective.
• In collaboration with the regional Operations teams, ensure ProPharma’s preparation for and participation in client audits and regulatory inspections.
• Create and align global quality goals and objectives with the strategic plans of ProPharma annually.
• Participate in senior management meetings and initiatives, where appropriate.
• Work closely with operations to identify and implement innovative solutions to improve efficiency and quality.  
• Monitor and understand emerging industry and regulatory trends.
• Work with other members of the global quality organization to ensure that the global Quality Management System is robust and sufficient to ensure the quality and regulatory compliance of ProPharma services and activities.

Essential Functions:

General:

• Develop and maintain global quality SOPs associated with PV quality and ensure integration at the regional and local level as appropriate.
• Responsible for the monitoring, measurement, assessment, and delivery of high-quality pharmacovigilance services for the Company’s clients, including identifying issues and proposing solutions.
• Develop, maintain, and manage processes and strategies to monitor, control and enhance the quality of the services provided to PV clients by ProPharma globally.
• Oversee the identification of quality failures, establishment of appropriate corrective actions and coordination of their implementation.
• Ensure that all findings and corrective actions are fully documented.
• Monitor monthly quality metrics for trends.
• Retrospectively review past performance overall and for specific clients to identify trends or patterns. This includes regular monitoring service levels and other key performance indicators.
• Responsible for the creation and maintenance of ProPharma’s SOPs and alignment with Working Practice templates.
• Maintain and develop processes and strategies to ensure compliance with Working Practices for specified clients and with ProPharma’s SOPs, globally and regionally.
• Collaborate with the management of site operations to support ProPharma’s preparation for and participation in client audits and regulatory inspections.
• Ensure that the Confidentiality Statement within the Contract of Employment is always adhered to by all members of the Quality Team in respect of the data and property of the Company and its clients.

Personnel Management:

• Directly manage the regional Quality teams including the following:
  • Direct oversight of each region’s quality management team for PV
  • Perform salary reviews and promotions for direct reports and subordinates.
  • Provide direction and oversight to direct reports for staff recruitment, training, mentoring, and motivational support for long-term professional development.
  • Disciplinary actions as required, in consultation with and under the direction of HR.
• Review workload and task allocation on an ongoing basis to ensure effective utilization of all members of the team.
• Promote team building and staff motivation within the Quality Team.

Reporting:

• Provide management reports to, and senior management as necessary, on a monthly basis with respect to any quality-related issues related to ProPharma processes or personnel.
• Lead periodic global PV Quality Committee Meetings.

Necessary Skills and Abilities:

• Excellent verbal and written communication skills.
• Ability to work collaboratively across regions within a matric organization.
• Strong interpersonal skills with the ability to present solutions in an understandable format.
• Ability to organize and prioritize in quickly changing environment within resource constraints.
• Proven record of successful supervision or management of personnel.
• Excellent attention to detail and focus on quality.
• Strategic planning abilities.
• Excellent computer literacy.
• Knowledge of quality management techniques and tools.
• Ability to anticipate issues, develop and offer solutions to minimize disruptions.
• Receptive to constructive feedback.
• Self-motivated. Ability to demonstrate initiative and internal drive with a high level of creativity, perseverance, and openness to change.
• Willingness to seek out additional projects.
• Able to develop and improve processes with minimal supervision.
• Willingness to travel.
• Working knowledge of Data Privacy legislation globally.

Educational Requirements: University/ Bachelor’s degree.

Experience Requirements:

• Minimum: 5 years of experience in a quality role and 10 years of experience in the pharmaceutical industry.
• Preferred: Experience in Pharmacovigilance and/or Clinical Safety.