DS&E Associate

Job description

Job Description

A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.

Job Purpose:
To support management of DS&E/PVO operational processes at Country Pharma Organization (CPO (Denmark and iceland) including NCH and NVD as per LOU and agreement) in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis, marketed and investigational products. Support DSE Scandinavia with various tasks.

Major Accountabilities:
1. Archiving all safety documentation as per respective policies, guidance and procedures.
2. Monitoring the compliance with support of DS&E Associate
3. Verification and update of respective CPO DS&E archiving system (incl. review, update, management)
4. Manage collection, processing, documentation, reporting and follow-up of all serious adverse events (SAE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), registries, and all adverse events from commercial, sales and marketing programs and all Spontaneous Reports (SR).
5. Transcribe, translate and enter data of all Serious Adverse Events (from Clinical Trials, post-marketing studies (PMS), registries) and all adverse events (from commercial, sales and mar-keting programs and all Spontaneous Reports) from source documents onto safety systems (e.g. Argus Affiliate, etc) accurately and consistently with emphasis on timeliness and quality.
6. Record and track receipts, submissions and distributions of SAEs, SRs, Investigator Notifica-tions (IN)/Suspected Unexpected Serious Adverse Reaction (SUSAR), Periodic Safety Report Updates (PSUR) and Development Safety Update Report (DSUR).
7. Manage reporting/submission/distribution of safety reports/updates/ information (e.g. SAE, SR, IN, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations.
8. Work with other local/global PVO associates to ensure accurate evaluation of safety data.
9. Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
10. Support in developing, updating and implementing local procedures
to ensure compliance with PVO global procedures and national requirements.
11. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
12. Management and maintenance of all relevant PVO databases.
13. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.

Desired profile

Education:
Secondary Education/A degree in medicine or pharmacy

Language:
Danish fluently. Intermediate/fluent knowledge of English (oral and written)

Experience:
Preferably experience on similar position in drug safety or drug registration or
clinical research department would be an additional asset.