Duchesnay Inc., located in Blainville, Quebec, in the Lower Laurentians, is a specialty pharmaceutical company with a long-standing commitment to women’s health. Until recently, the company focused on filling the void in terms of scientific research and education and on developing pharmacological solutions that are safe and effective for use during pregnancy and breastfeeding. Today, Duchesnay has broadened its portfolio of products to offer safe and effective therapeutic options that meet the health and quality of life needs of women and their family members at different stages of their lives.Duchesnay offers its employees state-of-the-art facilities and a stimulating and safe work environment.
Medunik Canada, a Duchesnay’s sister company also located in Blainville, is a specialized pharmaceutical company whose mission is to improve the health and quality of life of Canadian with rare diseases. To this end, the company works at commercializing orphan therapies currently not available in Canada. Visit our web site: www.medunikcanada.com
Role and Responsibilities:
The successful candidate will be responsible to:
- Provide safety information to healthcare professionals, consumers and medical sales representatives that are relevant, accurate, thorough, referenced and clear in an appropriate format (verbal and written) according to the approved product labelling and internal procedures
- Respond to requests for information on adverse drug reactions (ADR) post-marketing and in the clinical setting
- 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
- 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
- Liaise with external study centers and clinics regarding safety reports and product surveillance programs
- Provide support for health authority safety inspections
- Conduct literature searches and provide summarizes as needed
- Assist in drafting product labelling (Product Monograph, Health Professional Information, Prescribing Information, Package Insert) for regulatory submissions
- Contribute to the medical content of promotional materials and websites
- Multitask on projects across departments including, Regulatory Affairs, Medical Affairs, Research, Business Development and Marketing
- Demonstrates technical and scientific skills in the research and interpretation of scientific data
- Excellent written and analytical skills
- Excellent communication, documentation, organizational and interpersonal skills
- Autonomy, ability to work with minimum of supervision
- Ability to adapt and be flexible
- Bachelor of Science Degree (nursing or pharmacology related discipline preferred)
- Minimum 7 years of previous drug safety or pharmacovigilance experience in the pharmaceutical industry
- Ability to use a computerized database (knowledge of ARISg is an asset)
- Proficient Microsoft Office and internet skills
- Bilingual (English/French)
We offer a competitive salary and a full range of fringe benefits. This is a permanent position and available immediatly.
If you are interested and have the required qualifications, please submit your resume by April 2nd 2018
by e-mail: firstname.lastname@example.org
We thank all applicants for their interest; however, only selected candidates will be contacted.
Duchesnay Inc. is an equal opportunity employer.