Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.
At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.
This is a hybrid position with two days of remote work and three days at our head office in Laval.
Scope
- Act as a local PV contact person for local Health Authority
- Act as a local PV contact person for audits and inspections and inform GPRM of incoming inspections / external audits
- Establish, implement, and manage the MAH PV system, in accordance with relevant corporate procedures, Safety Data Exchange Agreements (SDEAs) and local regulations.
- Ensure creation, maintenance and updates of local pharmacovigilance SOPs / WIs in according with local regulations and in line with Global SOPs
- Oversight of local vendor / partner (s) conducting local PV activities
Key Activities / Responsibilities
Provide coordination and support for internal Pharmacovigilance activitiesEnsure collection of drug safety information in the territoryCan participate in translation, reconciliation and follow-up if neededContribute to Aggregate Reports Team needs by :o Acquiring data necessary for Aggregate reports preparation
o Contributing to Global Periodic Report schedule according to
authorizations / licenses in Canada
Implement, in conjunction with SDEA Team, local safety agreements with partnersSupport review of local SDEAs and compliance (especially with local PV contractors) in cooperation with the global SDEA teamMaintain the Canadian list of products in the Company Product DictionaryMonitor submission of Aggregate reports in collaboration with Regulatory AffairsLiaise with Global and local functions for pharmacovigilance activities, as definedMaintain the whole internal and external correspondence coming within her duties and activities and ensure relevant archiving of PV documentation if neededResponsible for informing (in collaboration with GPRM team) Canadian Medical and Regulatory team about any safety issues in CanadaSupport labelling safety update activitiesEnsure local literature review and monitoring of the CanadaVigilance website is in placeCollaborate with Medical Affairs, Marketing, Regulatory Affairs and partners to refine the RMP and aRMMS strategiesCommunicate any urgent safety issues to upper GPRM managementEnsure seamlessly integration of new acquisitions and divestmentsEnsure safety updates and 72 hours notifications are submittedEnsure local process for complaints / adverse events collection and reporting to GPRM is in placeEnsure inspection readinessManage or assist in management of PV audits and inspections from external regulatory agencies, partners or corporate auditors.Participate in preparing responses to safety related requests from Health AuthorityEstablish local metrics and other monitoring systems to measure and verify local compliancePrepare and manage local Non-Conformances / Deviations and CAPAParticipate in GPRM training activities and regular TCsOrganize PV training for local employees and local contract vendorsPerform Health Authority Website monitoring and inform GPRM of changes in local regulation pertaining to PharmacovigilanceEnsure business continuity and back-upQualifications / Training
University degree with Pharmaceutical / Medical / Scientific backgroundProven oral and written communication skillsLanguages : excellent French and English skillsTechnical knowledge of job-related systemsKnowledge of PV-related local regulations and understanding of International Pharmacovigilance regulationsComputing skills : user requiring advanced Literacy (Microsoft Office applications, Adobe Acrobat, Safety database)A minimum of 8-10 years of relevant work experience in PharmacovigilanceThe masculine is used in this publication without prejudice for the sake of conciseness.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
