Celgene Safety Data Specialist (Max Duration) in BOUDRY, NebraskaSwitzerland

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.

Purpose:

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 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 anddue 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

Qualifications

Qualifications:

  • B.S. or equivalent in a health related setting (or equivalent combination of education and experience)

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

Competencies

  • Attention to details

  • Time Management

  • Prioritization skills

  • Team working

  • Adaptability

  • Organization skills

  • Promote Open Communication

#LI-EX

Safety Data Specialist (Max Duration)

Location: BOUDRY, NE, CH

Job ID: 17001847