Celgene Junior Safety Data Specialist in Boudry, Switzerland

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

  • To co-ordinate the receipt and initial management of adverse event reports. To execute the distribution and tracking of adverse event follow up materials To manage the release of individual case safety reports from the drug safety department in accordance with defined practices Perform event/seriousness data entry and assessment into ARISg Monitor reminder and further follow-up need Perform Other Manufacturer Notification & any other licensed partner exchanges further to PV agreements

Context and Responsibilities:

The Safety Data Specialist role is a regional role based in Switzerland and UK Reports to Drug Safety Manager Safety Data Responsible for:

  • Initial AE case report completeness review

  • Determination of non-AEs

  • Initial receipt and data entry of AE and non-AE case reports

  • Assessment of non serious case reports

  • Identification of product quality reports

  • Distribution and tracking of follow-up materials

  • Final stages in case report management (release from Celgene) in accordance with defined procedures

  • Maintaining submission details within the corporate drug safety database

  • Maintaining case files to include source documentation and submission records where applicable

  • Translation of source documents as needed •Data completion Key Activities: Case Management

  • Co-ordinate the receipt of case reports, specifically:

  • Retrieve case in IRT •Check initial source doc completeness

  • Initiate follow-up if needed & log communication in ARISg CCM

  • Perform duplicate search and identify exact duplicate source do

  • Perform initial data entry in ARISg

  • Determine if AE / Non-AE

  • Identify Non-AE follow-up needs and generate letters and attachments

  • Identify PQ complaint and notify Quality Department

  • Execute exchange of information (e.g. contractual partners)

  • Perform data entry of cases into ARISg as per WP-G-503 and internal timelines per SOP-G-500

  • Perform assessment of non serious cases into ARISg as per WP-G-505 and internal timelines per SOP-G-500 Regulatory Submission

  • Maintaining submission details within the corporate drug safety database

  • Create CIOMS forms as needed

  • Create cover letters to support electronic and manual submissions

  • Create submission packages as required

  • Execute pre-defined follow-up measures and due diligence, specifically

  • Pull list of follow-ups to be sent by day

  • Send out follow-up letters

  • Update follow-up communication in ARISg CCM

  • Generate daily listing of cases that need subsequent follow-up and send subsequent follow-up letters/queries to ensure due diligence is performed •Initiate reminder of further follow-up as needed

  • Elevate outstanding follow-up (clinical trial case)

  • Log follow-up measures in ARISg CCM Internal Global Safety Dept Development •Demonstrate knowledge of and compliance with established document management processes, guides, policies, and SOPs.

  • Participate in the mentoring and training of new staff

  • Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

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.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE