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Safety Data Specialist (2 Year Maximum Duration Contract - Excellent Entry Level Opportunity)

Celgene Corporation
Date de publication


Safety Data Specialist (2 Year Maximum Duration Contract - Excellent Entry Level Opportunity)

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
•To create and maintain tracking details of individual safety reports distribution within the corporate safety database
•Perform event/seriousness data entry into ARISg
•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 reports to the Supervisor Responsible for:
•Initial AE case report completeness review
•Determination of non-AEs
•Initial receipt and preliminary data entry of AE and non-AE 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
•Initial and date stamp source document electronically
•Log receipt of self-evident follow-up as communication in ARISg
•Check initial source doc completeness
•Initiate follow-up if needed & log communication in ARISg
•Perform duplicate search and identify exact duplicate source doc
•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
•Attach all provided documents to case in ARISg
•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 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
• Distribute submission package to authority, CRO, license partner or Celgene department
• Create updated authority records with post-submission data (e.g. authority receipt date) 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
•Print, assemble and send follow-up letters/queries and attachments for all cases
•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 as communication in ARISg 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

Decision Making Authority
•Initial internal distribution of AE and non AE reports
•Determination of non-AE status
•Determination of Product Complaints
•Identification of AE reports flagged for follow-up
•Determination of outstanding follow up needs

•Initial AE case folder production, as applicable
•Initial AE case data entry
•Distributed follow-up requests
•Follow-up request tracking
•Completed safety reports
•Submission records within the corporate drug safety database and case folders


The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent. 

• B.S. or equivalent in a health related setting (or equivalent combination of education and experience) Or
• Commercial diploma or the equivalent combination of relevant education or professional experience qualification Experience:
• Minimum 1 year of experience in records management/data processing/medical transcription or Administration setting Knowledge:
• Familiarity with database usage
• Word processing experience
• Document management and archiving practices
• Strong English written and spoken
• Strong communication skills

•Attention to detail
•Time Management
•Prioritization skills
•Team working
•Organization skills