Pharmacovigilance Manager

Daiichi Sankyo; Toronto; On-site; CAD 100,000 - 140,000; Full time

Job summary

Daiichi Sankyo is seeking a Pharmacovigilance Manager for its Canadian affiliate in Toronto. This role involves ensuring compliance with regulatory requirements and overseeing the pharmacovigilance system, requiring strong communication and analytical skills. Applicants should have a relevant degree and significant experience in the field. Join us and contribute to better patient outcomes in an inclusive workplace.

Qualifications

• 5+ years with advanced degree, or 8+ years with bachelor's.
• Fluent in English and French.
• Strong knowledge of international and European PV laws.

Responsibilities

• Serve as primary contact for pharmacovigilance in Canada.
• Implement safety report collection processes.
• Maintain the EU Pharmacovigilance System Master File.

Skills

Problem Solving

Communication

Analytical Skills

Teamwork

Education

University degree in Life Sciences, Pharmacy, or Medical Sciences

Job description

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Pharmacovigilance Manager

Date : 30 Apr 2025

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries / regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas : Our Specialty Business aims to protect people from cardiovascular disease, the leading cause of death in Europe, and to help patients suffering from it enjoy every precious moment of life.

In Oncology, we drive innovation in solid tumours and blood cancers, based on breakthrough science from our labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, with affiliates in 15 European countries and Canada.

We are seeking highly qualified candidates for the position of Pharmacovigilance Manager at Daiichi Sankyo Pharma Canada Limited.

The Position

This role primarily serves as a Local Safety Officer (LSO) for our Canadian Affiliate, ensuring compliance with global and local pharmacovigilance (PV) regulatory requirements and overseeing the local PV system's operation by executing operational PV tasks. The role also involves acting as the local National PV Contact Person in Canada, implementing the DSE PV policy strategy, and liaising with stakeholders such as Regulatory, Medical Affairs, and Marketing, as well as PV vendors.

Additionally, the position supports the organization of a customer-centric medical information service in collaboration with medical personnel, reporting to the Medical Director DSCA.

Roles and Responsibilities

As LSO :

• Serve as the primary contact for pharmacovigilance in Canada.
• Implement and oversee safety report collection processes.
• Create and update local procedures in line with regulatory requirements.
• Act as contact for adverse event reporting from healthcare professionals and consumers.
• Perform literature screening, monitor PV legislation, and implement RMPs and risk minimization measures.
• Liaise with stakeholders and PV vendors, and provide PV training.
• Maintain the EU Pharmacovigilance System Master File (PSMF).
• Contribute to benefit-risk evaluations and respond to regulatory authorities.
• Prepare for and facilitate audits and inspections.
• Collaborate with the European PV team to enhance PV quality management.

As Interim MI Manager :

• Support medical information requests and implement related SOPs.
• Coordinate with stakeholders and vendors to ensure proper MI process implementation.
• Manage contracts and oversee vendor activities.
• Contribute to PV system improvements and data exchange agreements.

Personal Skills and Professional Experience

• University degree in Life Sciences, Pharmacy, or Medical Sciences; 5+ years of experience with an advanced degree, or 8+ years with a bachelor’s degree.
• Strong knowledge of international, European, and PV laws and guidance.
• Fluent in English and French, with excellent communication skills.
• Reliable, analytical, systematic, and proactive with problem-solving skills.
• Ability to work independently and in international teams, with a willingness to travel.

Why work with us?

At Daiichi Sankyo, you will have the opportunity to make a difference and contribute to better patient outcomes. We promote a culture of respect, inclusion, and continuous learning, encouraging you to grow and share your ideas. If you are proactive and passionate about patient needs, we look forward to your application.