Senior Pharmacovigilance Manager

Drive pharmacovigilance strategy as the Senior PV Manager for Henlius, ensuring compliance with Health Canada's stringent regulations. Utilize your expertise in safety profile management and regulatory interactions.

As the Senior Pharmacovigilance Manager at Henlius, your role involves leading all pharmacovigilance activities and ensuring that they align with Health Canada requirements. With a minimum of six years in pharmacovigilance and a clinical medicine background, you will collaborate with various teams to manage and review safety profiles. You will also serve as the primary point of contact for Health Canada during inspections and will be integral in driving compliance initiatives.

Key Responsibilities:

• Lead pharmacovigilance projects and ensure compliance

• Manage emerging safety profile concerns for products

• Review safety reports in collaboration with headquarter Physicians

• Serve as primary contact for Health Canada inspections

• Maintain comprehensive knowledge of applicable regulations

Requirements:

• 6 years of hands-on pharmacovigilance experience

• Clinical medicine background is preferred

• Strong expertise in Canadian PV legislation

• Familiarity with drug safety databases such as Argus

• Excellent presentation and interpersonal skills

Bring your expertise to Henlius and lead impactful pharmacovigilance initiatives in Canada.