Director, Pharmacovigilance

3 weeks ago

Laval, Canada Bausch Health Companies Full time

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.

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 activities

Ensure collection of drug safety information in the territory

Can participate in translation, reconciliation and follow-up if needed

Contribute 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 partners

Support review of local SDEAs and compliance (especially with local PV contractors) in cooperation with the global SDEA team

Maintain the Canadian list of products in the Company Product Dictionary

Monitor submission of Aggregate reports in collaboration with Regulatory Affairs

Liaise with Global and local functions for pharmacovigilance activities, as defined

Maintain the whole internal and external correspondence coming within her duties and activities and ensure relevant archiving of PV documentation if needed

Responsible for informing (in collaboration with GPRM team) Canadian Medical and Regulatory team about any safety issues in Canada

Support labelling safety update activities

Ensure local literature review and monitoring of the CanadaVigilance website is in place

Collaborate with Medical Affairs, Marketing, Regulatory Affairs and partners to refine the RMP and aRMMS strategies

Communicate any urgent safety issues to upper GPRM management

Ensure seamlessly integration of new acquisitions and divestments

Ensure safety updates and 72 hours notifications are submitted

Ensure local process for complaints/adverse events collection and reporting to GPRM is in place

Ensure inspection readiness

Manage 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 Authority

Establish local metrics and other monitoring systems to measure and verify local compliance

Prepare and manage local Non-Conformances/Deviations and CAPA

Participate in GPRM training activities and regular TCs

Organize PV training for local employees and local contract vendors

Perform Health Authority Website monitoring and inform GPRM of changes in local regulation pertaining to Pharmacovigilance

Ensure business continuity and back-up

Qualifications / Training

University degree with Pharmaceutical/Medical/Scientific background

Proven oral and written communication skills

Languages: excellent French and English skills

Technical knowledge of job-related systems

Knowledge of PV-related local regulations and understanding of International Pharmacovigilance regulations

Computing skills: user requiring advanced Literacy (Microsoft Office applications, Adobe Acrobat, Safety database)

A minimum of 8-10 years of relevant work experience in Pharmacovigilance

The 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.

Bausch Health is an EEO/AA employer M/F/D/V.

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