Apply Now    

Safety Data Specialist (Max Duration Contract)

Req #: 1800001
Location: Boudry, Boudry CH
Job Category: Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Travel:
Other Locations:Switzerland- Boudry

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.

Context and Responsibilities:

The Safety Data Specialist reports to Drug Safety Manager Safety Data  

Responsibilities:

Initial AE case report completeness reviewDetermination of non-AEsInitial receipt and data entry of AE and non-AE  case reportsAssessment of non serious case reportsIdentification of product quality reportsDistribution and tracking of follow-up materialsFinal stages in case report management (release from Celgene) in accordance with defined proceduresMaintaining submission details within the corporate drug safety database Maintaining case files to include source documentation and submission records where applicableTranslation of source documents as neededData completion

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 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 

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 performedInitiate 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

Qualifications:

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 years of experience in records management/data  

       processing/medical transcription setting

Knowledge:

   Familiarity with database usage   Word processing experience   Document management and archiving practices   Strong English written and spoken   Strong communication skills

#LI-EX

Apply Now    

Not ready to apply?

Join Our Talent Network

About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

Global Network

world map

HAVE A QUESTION OR CONCERN?
CONTACT US