Drug Safety Manager (PSUR-DSUR reporting), NL

Reference: OD10516

Expiry Date: 12-09-2020

Categories Biotech, Clinical Research

Salary: Competitive

Job Type: Contractor

Location:
Leiden
Netherlands

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Job Description

Drug Safety Manager (PSUR-DSUR reporting)

This is a contract role for a Manager leading and overseeing the periodic aggregate safety reporting and medical writing from vendors in Global Pharmacovigilance for a mid-size biopharma. This is with a drug discovery company investing heavily in R&D as well as its people.

Note: My client offers Digital Hiring and On-Boarding using Video Conferencing and the successful candidate will be inducted and trained remotely. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

About the opportunity

Have you authored/written PSURs/DSURs and you want to contribute to high quality standards of quality as well as benefits risk assessment documents in response to RA requests?

Do you want to bring your expert guidance and provide critical support to the product responsible persons by working closely while working closely with ES and RM members?

Do you want to be the person accountable for compliance with regulatory standards and timely delivery of all global/regional periodic documents while maintaining close cross departmental/divisional relationships with global PV, EU-QPPV, RA, GMA and clinical development?

If you find yourself answering yes to the questions above, please consider making your application.

Your background and experience

If you have over 2-5 years’ experience within health science related industry and have had direct exposure to compiling and reviewing PSUR/DSUR reports we’d be happy to hear from you.

Compensation

Up to 92 000 EUR basic.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Octavian or Matt on +44 (0)207 801 3387 or +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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