Safety Compliance Specialist

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 whereby 90% of our employees are proud to say they work for AbbVie and 88% are proud of how we contribute to the community.  

AbbVie’s 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 people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.  

When choosing your career path, choose to be remarkable.   

Are you looking for an exciting role, where development and high-performance are valued? AbbVie Canada is looking to connect with a Safety Compliance Specialist, to join our Pharmacovigilance team. This is a full-time role. This role will cover the Montreal city area.

The Safety Compliance Specialist’s principal responsibility is to support PV management in ensuring the affiliate PV system complies with local, global and regulatory requirements in the area of ICSR reporting from PV Partnership programs, clinical studies conducted in Canada and all other activities conducted by the affiliate including the quality system management and oversight of the outsourced PV partner/service providers.

Key responsibilities: 

Pharmacovigilance system

• Support the PV Manager, PV Partnerships and Head of PV in fulfilling the responsibility for the coordination and execution of all aspects of PV (drug safety) to ensure that all of AbbVie’s statutory and ethical responsibilities are met in the area of ICSRs. Liaise with Health Canada and Pharmacovigilance & Patient Safety Epidemiology R&D Quality Assurance (PSEQ) as required. 
• Act as the affiliate subject matter expert on the various systems used for ICSR reporting including but not limited to Trilogy, Veeva Vault Safety, and the Canada Vigilance electronic reporting system, liaise with key affiliate stakeholders Customer Relations, Quality Assurance, Medical Information, Patient Experience, Clinical Research, Trilogy team, PV Partnership vendors, PSEQ and Trading Partner Management Office (TPMO) and facilitate management of technical developments and issues as required.

Compliance oversight

• In collaboration with PV Manager, PV Partnerships, maintain oversight of all aspects of the performance and functioning of the Affiliate PV Partnerships and ICSR-related activities including compliance with local regulations, corporate requirements.
• Lead the monitoring of safety signals on a local level through the LASSIE (local safety surveillance tool) and the PV dashboard. Investigate the safety signals and report to management when needed.

Individual Case Safety Reports (ICSR) Management

• Responsible of ensuring that all of AbbVie Canada’s obligations as a Trading Partner in the Canada Vigilance electronic adverse event reporting system are met.
• In collaboration with the PV Manager, PV Partnerships and the Head of PV, act as the affiliate subject matter expert on ICSR reporting requirements and liaise with PV Partnerships vendors, Customer Relations, Clinical Research/Site Management, PSEQ and Health Canada’s TPMO as required to ensure compliance with adverse event reporting requirements in the post-marketing and clinical trial settings.
• Maintain oversight of AbbVie third party PV vendor activities to ensure proper alignment with Health Canada regulations.
• Liaise with PV partnership vendors and Office of Safety Operations (OSOP) to ensure compliance with ICSR reporting requirements.
• Support as required the OSOP/AbbVie third party PV vendor in oversight of local PV Partnerships vendors for ICSR reporting including quality control check, investigation of late reporting, issue resolution, etc.
• Support as required OSOP/AbbVie third party PV vendors in ICSR reconciliation activities including PV Partnerships program reconciliations, Canada Vigilance Reconciliations, literature searches, affiliate product complaints and medical inquiries, PMOS.

Audits and Inspection Management

• Support as required internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
• Support the development of CAPA in response to observations and completion of corrective/preventative actions in a timely manner.

PV Training

• Support the Head of PV in ensuring overall training compliance with global and local PV requirements and other mandatory training as assigned. This includes the development of additional PV training materials for PV partnership vendors as required.

OTHER RESPONSIBILITIES

• In collaboration with PV management, prepare and maintain PV SOPs on an as-needed basis.
• Completes other activities or projects that support the overall performance of the affiliate PV system including new reporting process for PV partnership vendors.
• Complete all required trainings on time (e.g. in the ComplianceWire system and the AbbVie Learning Center or as requested by management) and comply with AbbVie policies, procedures, guidelines, ethics, and regulatory requirements.
• Support management as requested in various activities such as the generation of compliance metrics/reports, process improvements, resolving compliance issues/process deviations, management of CAPAs, audit/inspection process, training, New Product Introduction/Launch Excellence process, etc.  
• Attend and actively participate in team, departmental, divisional, and global meetings.
• In collaboration with manager, prepare annual goals, performance assessment and development plan as required.

INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:

• Affiliate Regulatory Affairs, Quality Assurance, Customer Relations, Medical Information, Clinical Research, Clinical Site Management, Patient Experience.
• Affiliate Marketing, Sales and Operations personnel in order to ensure that all employees are trained and understand their responsibilities for reporting of any suspected adverse event.
• Global organizations such as PSEQ, E2B Team, OSOP, and Trilogy team.
• AbbVie PV Service providers (PSP, MRP vendors, etc.)

External Education/Experience Required:

• Bachelor’s degree in science or equivalent.
• Minimum of three to five years in a Pharmacovigilance role within the pharmaceutical industry.

• Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Information, Regulatory Affairs, QA, Customer Relations, Patient Experience)
• 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.

Essential skills & abilities:

• French and English language proficiency (oral and written).

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 Psychiatry, Therapeutic Specialist 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.  

• Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)

• Intermediate knowledge of: ComplianceWire, Document management. Systems, Trilogy, Veeva Vault Safety, CRM systems.

• Valid passport.

• Travel 20%

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

AbbVie 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.