Overall objective 

• Assume the role as deputy Safety Contact Person
• Responsible for the continuity of all PV activities in Canada

Role and Responsibilities 

• Fulfill role and responsibilities of Deputy Safety Contact Person
• Prepare and conduct PV training of local LEO Pharma employees and non-PV staff
• Develop and maintain current knowledge of product disease states, and Canadian regulations pertaining to PV practices
• Available for the EU QPPV when needed
• Support update of Global PSMF
• Responsible for PV interface with local health authorities
• Support audit & inspections
• Support bridging local to global and global to local by communicating transformations and changes related to the local organization
• Identify and implement improvements for PV processes and procedures
• Ensure regulatory reporting of cases from interventional clinical trials including DSUR
• Ensure regulatory surveillance of PV
• Ensure that a PV agreement is in place ( where relevant) for local initiated PSP, MR and social media activities and keep informed about IIS. Ensure to communicate about the initiatives
• Document and process adverse event information from solicited, study and spontaneous reports including basic case entry for all pharmacovigilance cases
• Ensure data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases
• Support and maintain a local system all pharmacovigilance cases
• Receive and initially document product complaints; forward information to the Quality Assurance team for processing
• Actively participate in departmental and various cross-functional project teams that may include Regulatory, Sales and Marketing, and Medical Affairs
• Understand current brand strategic plans and objectives and provide appropriate input into the development and evolution of these plans and their related tactics.
• Have an expert understanding of LEO Pharma's internal copy review SOP, policies, and processes and those of external copy review stakeholders (e.g. Health Canada, PAAB, ASC, and IMC)
• Participate in or lead Global Safety projects

• B.Sc. Pharmacy or equivalent, PharmD, MSc. Or Ph.D and 1 year experience in PV, OR
• B.Sc. plus minimum 3 years' experience in PV
• Solid knowledge of PV regulations
• Well developed written skills (oral and written); Bilingual (French/English) strongly preferred
• Computer literate in all Windows environment, using MS Office
• Solid technical skills