- Lead regular departmental meetings; document associated discussion and actions
- Maintain accurate storage and documentation of all MIPV activities
- Manage incoming information into MIPV department to ensure timely responses to internal colleagues and external customers
- Support the completion of Annual Safety Reports to meet Health Canada requirements.
- Support internal pharmacovigilance audits and Regulatory inspections including assisting in readiness activities and compliance monitoring.
- Review approved clinical trial protocols for required safety database notifications
- Perform reconciliation against the Canadian Vigilance database for new reports and follow up information
- Manage completion of Access to Information Requests and Health Canada Quality Assurance Reviews
- Perform lifecycle management for Canadian Medical Information letters and medical presentations
- Provide administrative support for training and governance projects.
- Assist the MIPV Lead as required with risk management activities.
- Assist in lifecycle management of MIPV Written Standards
- Supports periodic quality review of Medical Information and Pharmacovigilance activities
- Supports fulfilment of requests for unapproved products (e.g. Health Canada Special Access Program (SAP) requests) according to GSK policies and procedures. Monitors the amount of SAP product supply locally.
- Collaborates with team members to maintain current and relevant departmental content on GSK's Intranet
- Participates in ad hoc requests to support departmental or divisional activities.
- Collaborate with other members of the MIPV team to implement process improvement strategies
- Contribute to patient safety by reporting, in a timely manner, all adverse events identified during the interactions with customers in accordance with internal policies and training, including any follow up information received.
- Bilingual (fluent in French & English) in spoken, written and comprehension is preferred
- Knowledge of pharmacovigilance concepts and regulations in Canada
- Experience in pharmaceutical industry compliance an asset
- Energy and passion to service our patients and healthcare professionals
- Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook.
- Proven ability to be flexible and adaptable to changing work requirements and new computer technologies (specifically local & global tracking & reporting databases)
- Quick learner with ability to work in a fast paced and changing environment
- Well-developed communication skills including listening, summarizing, probing, clarifying
- Adaptive communication style with ability to influence and build relationships with others across Divisions.
- Diligent and detail-oriented with a proven ability to prioritize work and meet challenging deadlines.
- Creative problem-solving skills and sound judgment.
- Proven ability to develop and maintain positive work relationships with team members by
- Actively supporting and contributing to the efforts of other team members.
- Promoting cooperation, collaboration and flexibility in working with others.
- Being able to work, negotiate and manage conflicts with other people with the aim of achieving a common goal
- Demonstrated resourcefulness including taking initiative and following through.
- Degree in a Health Profession
- Bilingual English and French
Medical Information and Pharmacovigilance Intern - Mississauga, Canada - 837 GlaxoSmithKline Inc.
Description
Job Purpose:
The mandate of the Medical Information and Pharmacovigilance Service Associate (MIPV Associate) is to provide support to local medical information and pharmacovigilance activities for all marketed products and products in clinical trials including all Pharma, Vaccine and ViiV products.
Details (Your Responsibilities):
sites
Basic Qualifications:
This is an office-based role.
Preferred Qualification:
#LI-GSK
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 organisation 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.
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