Drug Safety Case Manager - Basel, Schweiz - Idorsia Pharmaceuticals Ltd.

Idorsia Pharmaceuticals Ltd.

Geprüftes Unternehmen

Basel, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options.

Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated
Drug Safety Case Manager to join our dynamic team

Responsibilities:

The Drug Safety Case Manager works in a team-oriented environment and is responsible for the booking, processing, reporting and record keeping of safety information in compliance with applicable global regulations and Standard Operating Procedures (SOPs) and guidelines.

Management of Safety Information_
Sort, collect, and assemble safety relevant information received in Global Drug Safety.
Book safety information in Argus Safety, search for duplicate and triage cases.
Send acknowledgement of receipt to reporters/investigators.
Responsible for complete case processing: triaging, data entry, coding of safety information, narrative writing, quality control and submission of AE reports to health authorities.
Identification of missing information and initiation of follow up requests in collaboration with Drug Safety Physician.
Daily monitoring of the workflow and work lists to ensure all cases are prioritized and processed as appropriate.
SUSAR submission to Investigators and IRBs/ECs, review submission requirements and ensure timely compliance with regulatory timeframes.
Quality System Documents_
Contribute to the development and amendment of assigned GDS operations quality system (QS) documents.
Ensures compliance to all Idorsia QS documents and procedures.
Additional responsibilities_
Contribute to GDS projects and process improvement initiatives as required.
Support data migration and cleaning activities as determined.
Provide training of new employees, colleagues or External Service Providers (ESP) on collection and management of AE case reports and safety information.
University degree in life sciences (pharmacy, nurse) or equivalent education in healthrelated field.
At least 2Year experience in safety or clinical data management.
Knowledge of medical terminology and general understanding of disease processes.
Solid knowledge of coding thesauri and medical/drug dictionaries.
Good knowledge of the EU and US safety reporting requirements.
Excellent organizational and problemsolving skills, interpersonal skills, and the ability to work under pressure and meet short timelines.
Computer proficiency (Word, Excel and PowerPoint) and ability to learn new systems.
Previous experience with safety databases is an advantage.
Ability to communicate effectively in English (spoken and in writing).

What Idorsia offers:

Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solutionoriented environment where you can make a difference
An innovative and open culture in a truly multicultural environment
A competitive salary and generous benefits

Work Location:
Basel Area - Allschwil

Country:
Switzerland

Business Area:
Global Clinical Development - Drug Safety Department

Schedule:
Fulltime

Job Type:
Permanent

Job ID:3929

_At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success._
**_We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees._