Risk Management Specialist Pharmacovigilance 15 month contract

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 groundbreaking 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.

AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology oncology neuroscience eye care virology womens health and gastroenterology in addition to products and services across its Allergan Aesthetics portfolio.

In collaboration with the Pharmacovigilance (PV) Manager Safety Operations the Risk Management Specialists 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 problemsolving and continuous improvements.
• Recognize and promptly escalate compliance issues to PV Managers.
• Lead various internal and crossfunctional projects as requested by PV Managers or Head of PV.
• Mentors team members and/or interns and motivates 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 safetyrelated 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 postmarketing) and submission to Health Canada as required.
• Assist Regional PV and the PST 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 update 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 asneeded 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 :

• Bachelors degree in Life sciences degree Master (an asset)
• Experience: 3 to 5 years of experience in a similar role.
• AbbVie strives to provide a French working environment for its employees in Quebec.Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement advanced amount of knowledge of English / Fluency in English is an essential requirement for the position of Internal Agency Lead including but not limited to for the following reasons: 
  • • English speaking employees outside the province of Quebec. 
    • English speaking clients outside the province of Quebec. 
    • Anglophone region outside the province of Quebec.  
• 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 AbbVies 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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