Médunik Canada, a Duchesnay's sister company located in Blainville, is a specialized pharmaceutical company whose mission is to improve the health and quality of life of Canadians with rare diseases. To this end, the company works at commercializing orphan therapies currently not available in Canada.
The main responsibility of the Senior Drug Safety Associate is to act as a reference in pharmacovigilance matters and provide tactical support by effectively contributing to the activities of the Pharmacovigilance group in order to ensure that the organisation is compliant with the rules and regulations of pertinent Regulatory Agencies.
- Process case reports according to the internal established procedure and to the federal Drug Safety regulations;
- Enter all requests for Drug Safety information in the computerized database system and generate reports as needed;
- Prepare and revise periodic pharmacovigilance reports;
- Contribute to the elaboration and updating of Risk Management Plans (RMP) for assigned products;
- Contribute to the preparation and revision of pharmacovigilance agreements and develop and nurture solid business relationships with our partners;
- Ensure that Duchesnay is compliant with Drug Safety regulations in the reporting of both expedited and periodic safety reports to the required health authorities in support of our post-marketing Drug Safety program;
- Provide support for health authority safety inspections;
- Conduct literature searches and provide summaries as needed;
- Assist in drafting product labelling (e.g., Product Monograph, Health Professional Information, Prescribing Information, Package Insert) for regulatory submissions;
- Prepare and review departmental Standard Operating Procedures in line with good pharmacovigilance practices;
- Provide pharmacovigilance training and support to the team and to external departments when required;
- Multitask on projects across departments including Regulatory Affairs, Medical Affairs, Research, Business Development and Marketing.
- Demonstrates skills in the clinical interpretation of scientific data;
- Excellent analytical skills;
- Excellent written communication and documentation skills;
- Strong organizational and interpersonal skills;
- Ability to adapt and be flexible;
- Excellent problem resolution skills;
- Proven ability to take initiative;
- Ability to adopt behaviors that promote a good work environment.
- Must be a Health Care Professional, preferable with a diploma in Medecine or Pharmacy (A bachelor’s degree in a scientific field with equivalent experience may also be considered);
- Minimum 5 years of previous Drug Safety or Pharmacovigilance experience in the pharmaceutical industry;
- Previous experience with writing Risk Management Plans as well as Periodic Safety Update Reports;
- Knowledge of Pharmacovigilance databases; experience with Argus an asset;
- Proficient knowledge of Microsoft Office and Internet;
- Bilingual (English/French, both written and spoken).
We offer a competitive salary and a full range of fringe benefits. This is a permanent position and available immediately.
If you are interested and have the required qualifications, please submit your resume.
- By e-mail: email@example.com
We thank all applicants for their interest; however, only selected candidates will be contacted. Medunik Canada/Duchesnay is an equal opportunity employer.