Risk Management Specialist, Pharmacovigilance (6 month contract)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.

When choosing your career path, choose to be remarkable.

In collaboration with the Pharmacovigilance (PV) Manager, Safety Operations, the Risk Management Specialist’s principal responsibility is to support risk management activities, in addition to product safety monitoring, periodic safety reporting, management of the Quality System, and audits & inspections activities.

Leadership:

• Support PV Managers in problem-solving and continuous improvements.
• Recognize and promptly escalate compliance issues to PV Managers.
• Lead various internal and cross-functional projects as requested by PV Managers or Head of PV.
• Mentor team members and/or interns and motivate them to achieve and maintain high levels of performance and compliance.
• Work with minimum supervision.

Product Safety Monitoring:

• Actively assist Manager with responses to Health Canada safety requests and liaise with Regulatory Affairs (RA) to enable timely notification to the Product Safety Team (PST) and the global RA and PV teams and appropriate response to requestor.
• Actively assist Manager with safety-related product enquiries/issues received from external stakeholders/vendors, working with Medical Affairs, RA, and the PST as required.
• Monitor incoming safety information and communicate changes or concerns to Managers for evaluation as needed.

Periodic Safety Reporting:

• Overview and manage Periodic Safety Reporting activities at the affiliate level.
• Lead the scheduling of locally required Periodic Safety reports (clinical and post-marketing), and submission to Health Canada as required.
• Assist Regional PV and the PST in the preparation of local annexes to Periodic Safety reports (if required) and ensure alignment and documentation of responsibilities between PSQ, the PST, RA, Regional PV, and Affiliate PV.
• Perform assessment of Periodic Safety reports (Periodic Safety Update Reports [PSURs] and Development Safety Update Reports [DSURs]) and document Affiliate PV review as per procedure.
• Ensure the addition of new clinical molecules to the safety database and to the periodic scheduling and withdrawals of discontinued products.
• Support Manager and RA in the assessment, reporting to Health Canada, and documenting of foreign safety actions.

Risk Management:

• Lead affiliate required actions in the Risk Management system (evaluation and documentation of Risk Management Plans [RMPs], Core Implementation Strategies, Local Implementation Strategies, approval, implementation, and tracking of additional risk minimization measures) for a given product portfolio, within required timelines and escalate potential issues to direct Manager and Head of PV.
• Coordinate and organize Risk Management meetings with required stakeholders and document discussions, decisions, and actions in the appropriate SharePoint Site, when required.
• Lead the development and updates of local annexes for RMPs and/or of the Canadian RMPs submitted to Health Canada in collaboration with RA, Medical Affairs, Market Access, the PST, and the Office of Risk Management.
• Lead safety requests related to Risk Management and provide local documents for the responses, when required.

Quality Systems:

• Stay aware of new or updated local legislation or regulatory intelligence impacting local processes and collaborate with Regional PV when updates to the local procedure and/or guidelines are required.
• Support Manager in the management of continuous improvement, PV CAPA process and exception reporting.
• Support Manager and Head of PV during audits or regulatory inspections.

Other responsibilities:

• Individual Case Safety Report (ICSR) Management - Support Regional PV in resolving issues related to the management of ICSR processing on an as-needed basis.
• Training - Complete all required trainings on time (e.g., in the Compliance Wire system, LERN, and the AbbVie Learning Center or as requested by Management) and comply with AbbVie policies, procedures, guidelines, and ethics, as well as regulatory requirements.
• Support Management as requested in various activities, scientific initiatives, and projects.
• Attend and actively participate in team, departmental, divisional, brand team, and PSQ meetings.
• In collaboration with Manager, prepare annual goals, performance assessment, and development plan as required.

Qualifications

• Bachelor’s degree in Life sciences degree, Master (an asset)
• Experience: 3 to 5 years of experience in a similar role.
• Advanced knowledge of English / Fluency in English is an essential requirement for the position of Internal Agency Lead.
• Builds and maintains strong relationships with affiliate colleagues (e.g., Medical Information, Medical Affairs, Regulatory Affairs, Patient Engagement, Market Access) and global colleagues.
• Learns fast, grasps the “essence”, and can change course quickly, where indicated.
• Raises the bar and motivates others to a higher standard of performance.
• Creates a learning environment, open to suggestions for improvement.
• Deals comfortably with ambiguity and uncertain risk.
• Acts consistently with AbbVie’s ethics, obligations, and local laws.
• Focused on compliance; identifies, manages, and escalates issues in a timely manner.
• Excellent organizational and project management skills.
• Reacts quickly and effectively in a fast pace, dynamic environment.

AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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