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 will develop Idorsia into one of Europe's leading biopharmaceutical company, 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 600 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for an enthusiastic and motivated SeniorSafety Report Writerto join our team !
- Acts as the lead author in close cooperation with the responsible Drug Safety Physician in the medical writing of periodic safety reports or other ad-hoc safety analysis reports.
- Supports Drug Safety Physician in the medical safety evaluation of identified safety signals detected or requested by health authorities.
- Participates in the preparation other types of submissions to Regulatory bodies e.g. Integrated Safety summary (ISS), Reference Safety Information (RSI) section of Investigator Brochure (IB) etc., as required.
- Collaborates with colleagues in DRA to ensure highest medical quality standards and timely release of reports.
- Contributes as the lead author/reviewer in the development and amendment of assigned GDS Medical Safety QS documents.
- Participates in the development, update, and maintenance of assigned Medical Safety templates e.g. DSUR, PSUR/PBRER etc.
- Training of new Safety Report Writers as appropriate.
- Coordinates the planned schedule (incl. timelines) and allocation of responsibilities for assigned regulatory aggregated periodic safety reports preparation and submission to Health Authorities.
- Acts as GDS representative in Clinical Trial Team (CTT) for specific clinical trials as determined.
- Gives feedback to GDS operation team regarding findings in Argus data and recommends Argus coding manual update and changes to the Argus QC tool to enhance the data quality as required.
- A degree in life science (e.g. BSc and/or MSc/PhD).
- English mother tongue or excellent English skills.
- Highly developed and proven medical writing skills.
- 3-5 years of experience as a medical writer, preferable in the pharmaceutical industry.
- Knowledge of regulatory document requirements and guidelines.
- The ability to work independently and as part of a team.
- The ability to work under pressure, to prioritize tasks, and to meet challenging deadlines.
- Strong analytical skills.
- Excellent organizational, problem solving, interpersonal and presentation skills.
- Computer literacy in Word, Excel and Power Point.
What Idorsia offers
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented 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: Allschwil- Basel Area
Business Area: Global Clinical Development - Drug Safety
Job Type: Permanent
Job ID: 2522
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.