At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers as well as serious immune inflammatory diseases.
As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Changing the course of human health through bold pursuits in science, and a promise to always put patients first.
Celgene has an opening for a forward-thinking and self-sufficient individual to join our Drug Safety team – this is to help with our growing studies and to ensure that our quality control levels stay high.
We have a requirement for a Drug Safety Specialist, mandated to manage safety data reported to Celgene Canada in accordance with corporate and regulatory requirements.
Reporting to the locally-based Drug Safety Manager, you will be working in a compact team, rotating your role through key tasks such as confirming receipt of cases, overseeing distribution / submission of follow-up, and then managing the follow-up letters (ensuring they are suitable to the Canadian market)
With an eye for multi-tasking and ability to use your natural communication skills in a team, you are someone with a life sciences background – this may be a combination of either:
- Bachelors in life sciences PLUS work experience in a pharmaceutical environment (pharma / biotech / Clinical Research Organisation)
- OR Work experience as a Pharmacist or Nurse
Please note, for headcount purposes this is a contract position, lasting 15 months.
Responsibilities include, but are not limited to:
- Management of Adverse Event (AE) case data through the receipt and triage of local AE reports received from Health Care Professionals or consumers.
- Reporting of such to Global Safety via the global safety database.
- Initiation and conduct of follow-up activities related to local AE reports including direct telephone follow-up as required.
- Assessment of local and global clinical trial and post marketed serious AE reports for submission to Health Canada in accordance with federal requirements.
- Support senior team members in training activities related to Drug Safety & AE reporting both internally and externally.
- Assist senior team members in the management and maintenance of good customer relationships both internally with the Celgene Affiliate office and externally with key customers.
- Assist in responding to safety inquiries received from Health Care Professionals or Health Canada.
- Maintenance of high compliance standards with respect to reporting timeliness and quality of local AE data.
- Ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times.
- Champion Celgene Values.
- Bachelor of Science degree required, preferably with a background in Pharmacy or Nursing
- Previous clinical or related experience in a pharmaceutical environment
- Good clinical knowledge of therapeutic area, patient populations and drug class
- Excellent computer skills with full proficiency of MS-Office Applications
- French language skills preferable
- Knowledge of Health Canada requirements with respect to ADR Reporting and Pharmacovigilance activities
- Self-starter with superior time management skills, and ability to work independently or in team
- Very strong attention to detail
Committed to Improving the Lives of Patients Worldwide
Passion for the Patient:
We share a belief that what we do matters to the world—that it is essential to the advancement of healthcare. And that how we do it is what sets us apart from those who have come before us, as well as those we will meet in the future.
Courage to Face our Challenges and the Unknown
We willfully face the challenges of the past and the uncertainties of the future. We embrace the unknown, pioneering new science and new ways of doing business. Our willingness to challenge the status quo and take on risk is what enables us to create new standards in medicine, and the broader world of human health.
Trust in Our Words and Our Actions
We assume the best in each other—in terms of capability and intention—and we treat each other with dignity and respect as we work together to always do what’s best for Celgene. We value each
individual for the integrity they bring to their work and their relationships, both internal and external.
Excellence in Delivering Exceptional Results
We hold our work to the highest of standards—quality, scientific, and ethical. We also hold each other to equally high standards in the way we work, encouraging creativity and simplicity in problem-solving, transparency in communicating, and results that are data-driven.
Curiosity and Continuous Learning
We embrace curiosity and continuous learning.
We Assume the Best
We start from a place of inquiry, honoring diverse points of view, seeking to understand each other and giving everyone a chance to be heard.
We Debate Openly, Honestly and Completely
We share our views or disagreements fully in every conversation to encourage the best ideas to emerge.
We Make Decisions Objectively and Transparently
We are clear about our roles, include the right people in the conversation, consider the facts, and share our reasoning.
We Align and Follow Through
We carry out the decisions we make as a team, and agree to a process for changing and communicating them.
A Global Mindset
“Big company success, small company feel”
We engage our global colleagues in the discussions and decisions that shape who we are and how we behave—within Celgene and throughout the world. We honor the decisions that affect our daily work, and respect the process for changing them.
“We are focused on the right things”
We prioritize our work according to the stated vision and goals of the company. We take ownership of our role in contributing to the success of Celgene—adjusting timelines, budgets, and people—in response to official changes in our corporate priorities.
An Aligned Organization
“We are in this together”
We coordinate our resources and make trade-offs in ways that benefit the whole. We understand that our decisions and our work have an impact on others and we act accordingly, sharing responsibility for outcomes and avoiding the blame-game. We embrace processes that allow us the freedom to create and the ability to solve problems together.
An Engaged Workforce
We honor the contribution that each person makes—on the front lines, at the bench, or in the back office. We encourage each other to take on new responsibilities and explore new areas of growth. We respect that people have full lives and do what we can to create work-life balance.
“We are all in the know”
We are accessible to each other and communicate mindfully, respecting cultural norms of tone, time zone, and responsiveness. We ensure that the information people need to do their job is available and accessible.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.