Detail

Salary
negotiable
Location
North York, Toronto, ON, Canada
Posted by: Leo Pharma
05 Dec
148 Views
03 Feb EXPIRED

Pharmacovigilance Specialist, North York, Ontario

North York, Toronto, ON, Canada
Job Description

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
Job ID Reference
1637
Desired Skills & Experience
  • 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
Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 North York, Toronto, ON, Canada