Pharmacovigilance Specialist, Nort...

Role Description

ThePharmacovigilance Specialist represents LEO Pharma Inc. assumes the role as deputy Safety Contact Person. They will be 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
  

Pharmacovigilance & Compliance with Adverse Events

• Recognize that PV cases may come to your knowledge in this role and fulfil the responsibility to forward any adverse event and patient safety cases to the local Pharmacovigilance department in accordance with company policies
  

General

• Ensure compliance with appropriate SOP's, policies and guidelines.
  
• Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP's, guidances are issued.
  
• Participate in personal development and training sessions as required for the position.
  
• Work in a safe manner that does not endanger yourself or co-workers. Report any health or safety concerns (internal and external) in compliance with LEO Pharma policy and standard procedures.
  
• Strive to consistently uphold LEO Pharma's core values.
  
• Execute other duties as may be required by Executive team members and other members of LEO Pharma's Management team as training and experience allow.
  

Requirements:

• 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
  

Behavioural competencies

• We keep patients at the heart of what we do
  
• We innovate and improve
  
• We engage and enable our people
  
• We collaborate across and beyond LEO
  
• We execute and deliver