Pharmacovigilance Officer

**Date posted**:Aug 14, 2023**City**:Laval**Country/Region**:CA**Type of Contract**:Unlimited contract**Job Requisition ID**:3919Pharmacovigilance Officer
- Servier Canada, with its main office located in Laval, Quebec is a subsidiary of the Servier Research Group, an international pharmaceutical company governed by a foundation, with its headquarters in France. With a strong international presence in 148 countries, Servier employs 21,600 people worldwide. Entirely independent, the Group reinvests 25% of its turnover in Research and Development and applies all profits towards development. The Group’s growth is driven by a constant search for innovation in five areas of excellence - cardiovascular, immuno-inflammatory and neuropsychiatric diseases, as well as cancer and diabetes in addition to its activities in high-quality generic drugs.- Servier Canada's goal is to create a climate of mutual support and encouragement throughout our organization. We make every effort to achieve this through our work-life balance initiatives, our competitive benefits programs, employee development and our reward and recognition programs. At Servier, we believe that the key to success lies in our most valuable asset: our employees.- We are currently recruiting for a
- **Pharmacovigilance Officer** within the PV department and who will be Reporting to the Senior Pharmacovigilance Manager.**Status of position**:Permanent, full-time starting immediately**Location of position**:Laval (Only 1 day per week at the office. The rest will be remote)- Role Purpose:
- To support pharmacovigilance activities related to all aspects of drug safety for marketed products (or those in clinical trials as required).- Responsibilities:
- Working in close collaboration with the Local Responsible Person for Pharmacovigilance (LPV) and with relevant departments and individuals, both locally and centrally, to perform PV tasks as follows:
- Collection, processing, follow-up and transmission of Individual Case Safety Reports (ICSRs) from all sources to Global Safety and Licensing Partners in accordance with company SOPs and as per applicable PV Agreement;
- Assessment of submission eligibility of CIOMS received by the local PV department (from Licensing Partners) and ensuring submission to Health Canada as per the regulatory requirements;
- Participate in preparation of the relevant monthly reports of PV information (reconciliation and compliance) with internal and external stakeholders (Quality Assurance, Medical Information, Global Safety, Licensing Partners, CROs) as required;
- Collaborate in the implementation of Post Authorization Programs (as requested), considering the RMP (if applicable) and the type of study;
- Collaborate in the preparation, review, update and implementation of Pharmacovigilance Agreements with Third Parties and PV clause in local contracts and agreements;
- Collaborate in the preparation/update and implementation of local procedures (SOP/OPM) and other quality system documents in compliance with central procedures, local regulations, contracts and other directives;
- Collaborate on periodical local literature screening (as applicable);
- Assist in management and archiving of received aggregate reports (e.g., Annual Summary Reports, PSUR, PBRER, and/or DSUR);
- Participate in the management of Compassionate Use / Special Access Program requests in Canada (as agreed);
- In relation to the above activities, assist in initial and on-going training of internal or external staff (as requested) including maintaining the documentation of all the PV training provided;
- Maintain up-to-date awareness of local regulations related to pharmacovigilance of marketed products (and clinicals trials as applicable), cosmetovigilance and materiovigilance, and if applicable to comply with national and international regulations concerning medicinal products, cosmetics and devices;
- Communicate with Global Safety, other relevant Head Office structures, Licensing Partners, and health professionals or other third parties as appropriate, in relation to the above activities;
- Follow, in all activities, the relevant SOPs and OPMs issued by the Company;
- Perform general administrative tasks linked with PV activities (tracking, filing, archiving) as per relevant SOPs/OPMs and using local tools (as required); Prepare, submit, and file applicable documents to regulatory authorities;
- Contribute to the maintenance of a PV business continuity plan in accordance with corresponding local procedures;
- Participate in the preparation of internal and external audits or inspections by the Competent Authorities of the local Pharmacovigilance system;
- Assume the role of Deputy Local Responsible Person for Pharmacovigilance (LPV) for all aspects of pharmacovigilance activities in the absence of the Local Responsible Person for Pharmacovigilance;
- Undertake, in specific situations, other tasks which are directly related to the above competencies, skills, and