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About the Role

The Manager, Pharmacovigilance (PV) and Medical Information (MI) will be an experienced professional with expertise in Canadian PV and MI. This role is responsible for overseeing and managing Kye’s PV system and medical information queries for all therapeutic areas and disease states that Kye manages. As a member of the Scientific Affairs (SA) team, the Manager, PV and MI ensures compliance with all local regulations and requirements. The Manager, PV and MI will work collaboratively with leadership to problem solve, think creatively, and execute company objectives related to PV compliance and response to MI inquiries. This role will also provide accurate and consistent expert medical and PV advice to internal teams and liaise with external customers regarding PV agreements and procedures.

Responsibilities

Providing accurate and consistent subject matter expertise in all aspects related to PV and MI in a timely manner.
Oversee all PV activities.
Monitoring local PV and MI inboxes.
Manage MI responses to clinicians and patients in collaboration with Medical Affairs.
Co-develop MI letters for reactive support of consumer inquiries in support of new product launches.
Intake, processing and/or reporting adverse events to Health Canada (and/or partners) using appropriate forms and documentation practices within the required timelines.
Conducting routine literature, regulatory authority, and foreign action surveillance for reportable ICSRs and/or actions.
Writing narratives for adverse or other reportable events as appropriate.
Lead the management of partner agreements.
Filing source documents in collaboration with the third-party PV vendor.
Work collaboratively with third party vendors to achieve appropriate PV compliance.
Maintaining understanding of current local requirements/regulations while continuously monitoring and educating the internal team.
Executing and or reviewing relevant SOPs for medical information management, the receipt, collection, and submission of drug safety reports, literature reviews, and follow ups.
Ensuring the PV system is maintained inspection-ready with appropriate documentation and reconciliation practices and leading all audits on behalf of the company.
Manages signal assessments and trending analyses and providing quarterly updates to brand leadership.
Contribution to and/or preparation of product specific Risk Management Plans, as needed.
Maintaining, updating, and conducting PV training, as needed.

Requirements

Minimum 2 years experience in a pharmaceutical industry pharmacovigilance/drug safety/medical information department.
Competent knowledge of pharmacovigilance regulations and requirements with the ability to interpret and apply this knowledge as needed.
Highly experienced with processing drug safety cases.
Knowledge of medical terminology and ability to write scientifically.
Strong analytical skills and detail oriented.
Strong interpersonal and communication skills.
Customer facing communication experience.
Self-motivated and able to work with minimal supervision.
Strong organizational skills and problem-solving ability.
Ability to multi-task and adapt to dynamic work situations.
Demonstrated ability to meet timelines.

Skills

Pharmacovigilance
Medical Information
Drug Safety
Regulatory Compliance
Literature Review
Risk Management Planning
Training
Data Analysis
Communication
Problem-Solving
Organization
Multi-tasking

Location

Toronto / GTA

Work Type

Hybrid office/home based
Full-time

Experience Level

Minimum 2 years experience

Education Level

Advanced degree in the field of life sciences
Qualified health professional with a degree in Medicine, Nursing or Pharmacy preferred
Clinical experience is strongly preferred

Salary/Compensations

Compensation will be based on the candidate’s experience, background, and qualifications.

Benefits

Eligible for a company bonus (depending, in part, on company and individual performance).
Comprehensive benefits program including participation in our group benefits program and retirement savings program.
Vacation.
Certain time off and leave of absence benefits.
Well-being benefits (e.g., employee assistance program).

About the Company

Kye Pharmaceuticals Inc. is a Canadian pharmaceutical company committed to bringing value to Canadians with medicines that fulfill clinically significant unmet needs.
Recognized as one of Canada’s Top Growing Companies in 2025, our experienced team offers expertise in the Canadian pharmaceutical landscape from registration through to commercialization.
With a rapidly growing portfolio of in-licensed prescription medicines, Kye has an immediate opening for a Manager, Pharmacovigilance and Medical Information.
The successful candidate will join a team of highly motivated professionals committed to building a growth-stage organization with start-up agility based on scientific and medical integrity.