Medical Information and Pharmacovigilance, Operations Specialist

Job Purpose:

The primary purpose of this role is to ensure seamless communication and operational excellence within the department. This position is crucial for the effective management of departmental communications, coordination of special access programs, management of local Medical Information materials and maintenance of accurate reconciliation against external human safety information sources. The role also entails meticulous documentation management within validated systems and diligent management monitoring. Additionally, the position supports various projects and audits, ensuring compliance and enhancing overall departmental efficiency.

Key Responsibilities:

• Triage and action departmental communications
• Coordinate Special Access Program
• Maintain tracking of reconciliation against the Canada Vigilance Adverse Reaction Database
• Manage compilation and quality review for Annual Summary Reports
• Maintain documentation and tracking of departmental tasks and activities such as management monitoring and compliance, medical information content, clinical trials, training plan, Health Authority requests, and monthly meeting minutes with key Third Party Vendors
• Coordinate departmental meetings
• Manage Archiving
• Maintain departmental online content
• Perform management monitoring (self-audit)
• Provide Project support
• Provide audit and inspection support
• Contribute to patient safety by reporting, in a timely manner, all adverse events identified during interactions with customers in accordance with internal policies and training, including any follow-up information received.

Education Requirements:

Undergraduate degree in Health Sciences. Advanced or Health Professional degree (e.g., Masters, Nursing, Pharmacy) is preferred.

Job Related Experience (Minimum Requirements):

1-2 years of experience in coordinating departmental operations. Project experience in process improvement and experience working in GxP environment preferred.

Nice Haves:

• Bilingualism (French/English)
• Effective communication
• Documentation management
• Commitment to quality and accuracy
• Adaptability to new systems and processes
• Knowledge of pharmacovigilance concepts and regulations in Canada

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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