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.
The Duchesnay pharmaceutical group is the proud holder of the CONCILIVI seal. This award is a formal recognition of our efforts to provide work-life balance for our employees.
The Drug Safety and Medical Information Director will be responsible for leading a team of professionals responding to medical inquiries pertaining to company products, documenting adverse events and performing overall safety surveillance activities per Canadian, American and international standards for marketed products and/or products under development.
Key Responsabilities
- Act as the strategic lead for Medical Information and Pharmacovigilance responsibilities by ensuring the services offered by the team adequatley support the organisation’s current and future activities;
- Oversee the management of the department’s quality system to ensure overall performance, compliance, and inspection-readiness;
- Perform and/or review and approve medical assessments pertaining to individual case safety reports (ICSR), periodic benefit-risk evaluation reports, signal detection assessments, and risk management plans;
- Contribute to or assist their respective teams with the drafting and/or review of regulatory documents related to their area of responsibility as they pertain to new product submissions and/or launches;
- Cultivate and foster a culture of continuous improvement, both inter and intra departmentally.
Qualifications
- Qualified health professional;
- At least 10 years of experience in Pharmacovigilance-related roles and 2 years of experience in Medical Information-related roles, including management responsibilities;
- Excellent knowledge of Pharmacovigilance and Scientific Communication Standards and Requirements for Canada and United States. Knowledge of European or other jurisdictions requirements an asset;
- Demonstrates technical and scientific skills in the research and interpretation of scientific and regulatory data;
- Knowledge of Medical information and PV databases (knowledge of IRMS-Web and/or ARGUS is an asset);
- Proficient Microsoft Office;
- Bilingual (English/French, both written and spoken).
Competencies
- Proven strategic thinking, business acumen, risk evaluation and negotiation skills;
- Ability to organize activities and multitask, and possess good decision making skills;
- Strong Interpersonal/facilitation skills; Capable of influencing audiences at all levels, both within and external to the organisation;
- Demonstrates a flexibility/collaborative mindset;
Benefits
- Permanent position of 35 hours / week;
- Monday to Friday daytime schedule;
- Work in hybrid mode;
- Competitive salary;
- Paid vacation from the first year;
- Warm and friendly atmosphere;
- Group insurance plan and pension plan with employer contribution;
- Bank of sick and personal leave;
- Employee and Family Assistance Program;
And even more!
If you want to participate in the success of a company that cares about your work, apply now.
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 e-mail: cv@duchesnay.com
We thank all applicants for their interest; however, only selected candidates will be contacted.
Duchesnay Inc. is an equal opportunity employer.