Medical Advisor/deputy National Safety Officer

6 months ago

Toronto, Canada Calea Ltd. Full time

**_Caring for Life. Make a difference. Be the difference._**

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.

We are currently seeking a full-time** **Medical Advisor, Deputy National Safety Officer - Pharmacovigilance** to join our team

***

The Medical Advisor, Deputy National Safety Officer assists the Manager, Vigilance with medical expertise, drug safety data processing, evaluation, reporting, record keeping and quality control in accordance with Health Canada guidelines and Global Vigilance requirements. Also helps to manage the safety data processing in the Vigilance group for the Company's pharmaceutical drug products.

The incumbent serves as the main contact point in the company in terms of medical expertise for pharmaceutical drugs as Colloids, IV Drugs, Parenteral nutrition, and Standard Solutions. For e.g., review of product monographs and advertisement/promotional materials. In addition, the Medical Advisor, Deputy National Safety Officer assists the Manager, Vigilance and the Vigilance team members with all drug safety related activities and internal/external audits and inspections.

This position is responsible for keeping up to date with Canadian and international regulatory developments in the vigilance area (pharmaceuticals, biosimilars and medical devices). The role also provides input in the development and maintenance of local SOPs to ensure compliance with domestic regulations and corporate guidelines related to the reporting of adverse reactions, and assists the Manager, Vigilance and team with follow-up of all risk minimization measures as part of a risk management plan when applicable. Maintains high compliance standards with respect to reporting timelines and quality of local ADR data, medical device mandatory problem reporting and performs other medical and vigilance related duties as assigned.

**QUALIFICATIONS**
- University degree Medicine
- Advanced background in Health Sciences, Pharmacy, Biomedical Sciences
- Minimum combined experience of 4 years in vigilance/medical information/medical affairs
- Extensive knowledge and experience with safety case processing (both clinical and spontaneous)
- Knowledge of relevant Health Canada regulations and ICH guidelines pertaining to PV and risk management plan
- Experience in compiling PSURs, RMPs
- Experience in handling Health Canada inspections and external/internal audits
- Experience with the Adverse Reaction Information System Global Database (ARISg)

**SKILLS**
- Excellent communication skills (written and verbal). Written/verbal French is an asset.
- Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
- Strong computer skills in Microsoft® Office, PowerPoint, and Adobe Acrobat
- Self-motivated and able to work with mínimal supervision
- Strong attention to detail with the ability to multitask and handle fluctuating workloads
- Excellent organizational, interpersonal, and problem-solving skills
- Excellent continuous improvement skills
- Proven ability to adhere to standards and procedures and maintain confidentiality
- Strong scientific writing skills
- Sense of prioritization
- Fresenius Kabi Canada is responsible for ensuring we can provide critical and lifesaving medical products and services to vulnerable members of our communities. We are committed to fostering a caring culture, a safe environment, and a healthy workplace for all employees. Everyone must follow safe work practices and comply with our health and safety policies, vaccination policy and Covid-19 protocols._
- The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us._
- Fresenius Kabi Canada is an Equal Opportunity

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