Position Title: Deputy Director of Regulatory Affairs and Pharmacovigilance
Request number: 16061
Job Category: Administration
Division: Mc – Brunet / McMahon / Jean-Coutu (80069016)
Department: Pharmacy
Workplace: METRO – PRODOC (#M-PDOC)
Province: Canada : Quebec
Type of employment: Permanent
Pro Doc is a Quebec manufacturer of generic drugs established in 1955, a subsidiary of the Jean Coutu Group since 2007 and recently, an integral part of the pharmaceutical division of Metro Inc., bringing together the Brunet and Jean Coutu pharmacies.
SUMMARY:
Under the responsibility of the Quality Control / Assurance and Regulatory Affairs Director, the incumbent has the following responsibilities:
SPECIFIC RESPONSIBILITIES:
Regulatory Affairs
– Follow up on updates to the various regulations (law and regulations on food and drugs, DPT, PM, NOC guidelines, labeling, etc.) and assess their impacts on the various products marketed by Pro Doc;
– Checks and approves requests and / or changes related to DIN & NPN with Health Canada.
– Checks and approves monograph updates for submission to Health Canada.
– Supervises the requests for registrations / withdrawals to provincial forms;
– Supervise the registration of new products with wholesalers and other stakeholders (private insurers, automation companies, etc.).
– Supervises the updates of printed material (labels, boxes, leaflets, etc.).
– Approves the specifications of the printed material.
– Deals with regulatory authorities (Health Canada, INESS, RAMQ or others).
– Deal with the various suppliers / partners.
– Assign UPC codes and maintain electronic register
Pharmacovigilance
– Writes and reviews certain standard operating procedures (SOPs);
– Supervises the answers to pharmacological questions of outpatients, pharmacists, hospitals, insurance companies and others.
– Ensures the documentation as well as the notification and follow-up of reports of adverse reactions and unusual inability to produce the expected effects (RID) with suppliers and / or Health Canada when required according to the procedures and agreements in force.
– Oversees the preparation of annual summary reports submitted to Health Canada.
– Obtains the opinion of a health professional when required.
– Is responsible for the journal “Pro Tech” for ATP (s) and the competition “decipher the ordinance”.
Other
– Coordinates and supervises the work of the regulatory affairs & pharmacovigilance specialist.
– Replaces the packaging operations manager, as needed;
– Replaces the quality control coordinator, if necessary
– Performs all other related tasks.
ELIGIBILITY CRITERIA AND SKILLS:
– Hold a bachelor’s degree in science or equivalent training.
– Have a minimum of five (5) years of relevant experience in a pharmaceutical environment.
– Mastering Microsoft Office software (Word, Excel and Outlook).
– Have good communication skills (written and verbal) in both French and English.
– Demonstrate a highly developed analytical sense.
– Have a good knowledge of Good Pharmacovigilance Practices (BPV) and Canadian regulations concerning pharmaceutical products.
– Have an ease to understand and interpret regulatory texts.
– Demonstrate a sense of responsibility, organization and planning.
– Having good interpersonal skills, diplomacy and initiative.
– Demonstrate a good team spirit.
Metro values, respects and relies on the differences and skills of its employees from all walks of life. We will consider all qualified applications.
Only selected candidates will be contacted.
We respectfully ask agencies not to contact us or send us unsolicited applications.
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