Key Responsibilities:

• Acts as Regional PV Lead to fulfill and oversee local PV activities to ensure compliance with FDA and Health Canada requirements with the support from Henlius global PV system.
• Contributes Henlius global PV system, including its quality system, such as PV-related procedural documents (e.g., SOPs), PV training of personnel, Audit associated documents, PV system deviations and related CAPAs, to ensure fully compliance to FDA and Health Canada requirements.
• Manages the medicinal products’ safety profile, including any emerging safety concerns.
• Cooperates with drug safety physicians from headquarter for the medical review of safety reports and or safety relevant document.
• Acts as a PV point of contact to FDA and Health Canada and as a primary contributor for PV inspections from FDA and Health Canada.
• Maintains up-to-date knowledge of current FDA and Health Canada PV regulations and collaborates with relevant functions on implementation of changes in regulations.
• Has awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to the safety or the safe use of the products.
• Is aware of the content of Risk Management Plans (RMPs) and local appendix and provides input as needed.
• Has awareness about additional Risk Minimization Measures (RMMs) and Risk Evaluation and Mitigation Strategy (REMS) and manages the local implementation as needed.
• Is involved in the review and approval of protocols of any Post-Authorization Safety Studies (PASS) conducted in US and Canada.
• Ensures a full and prompt response to any request from FDA and Health Canada for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product with support Henlius global PV.
• Provides input into the preparation of regulatory action in US and Canada in response to emerging safety concerns (e.g., urgent safety restrictions, and communication to patients and healthcare professionals);
• Reviews any contractual and or PV agreements involving US and Canada territory with relevant parties (vendors, distributors, affiliate etc.) to ensure adequate address of all pharmacovigilance responsibilities.

Education:
Clinical Medicine background preferred.

Experience:
6 years of direct PV experience (mandatory requirement). Drug Safety Physician working experience preferred.

Skills and Competencies:

• Demonstrate expert knowledge in US and Canada pharmacovigilance legislation, skilled and knowledgeable in all aspects of pharmacovigilance, PV system and relative function.

• Familiar with products safety profile management.

• Strong interpersonal and presentation skills; exhibits professional maturity, confidence, and competence.

• Computer skills (e.g., Word, Excel, Outlook, SharePoint).

• Fluent in English.

• Excellent organization skills and sense of urgency/working to tight timelines.

• Ownership of tasks, open mind, flexible, good communication.