Pharmacovigilance Specialist - North York, Canada - LEO Pharma Inc.

LEO Pharma Inc.

Verified Company

North York, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

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 nonPV 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, followup 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 crossfunctional 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 coworkers. 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