Drug Safety Officer

Deputy Drug Safety Officer - Leiden - 9 month contract

Type: Contract - 9 months

Location: Leiden (home-based for now)

Start Date: ASAP

End Date: 31/03/2020

FTE: 40hrs

Are you an experience Drug Safety Officer looking for a new role within a multi-national pharmaceutical organisation? Do you want to serve as a point of contact for the PV Regional HQ functions?

For our client, we are looking for a Deputy Drug Safety Officer to be based in Leiden, Netherlands. In this role, you will be responsible for managing its related duties and act as a contact person for any safety issues at the responsible country and/or Affiliate.

Other responsibilities include

* Management of Product Safety Information (PSI)

* Ensure safety information by the Affiliate are collected and forwarded to the regional PV HQ in adherence with timelines, quality guidelines and standards
* Maintain caseload and monitor interactions with vendor

* PV Quality and Compliance

* Filing, storage and archiving of PV documentation is in accordance with PV regulations
* Support PV audit or inspection if needed
* Ensure compliance with local and regional PV regulations

* Maintenance of PV system and Oversight

* Input for PSMF regarding Affiliate communication to GPV Regional HQ

* Accountable for PV self-assessments, PV audits/inspections at the Affiliate and assist in developing CAPAs

* Ensure oversight and monitoring of all local studies and projects, including digital media

Requirements

* Bachelor's degree (Science or Technology preferred)
* 2+ years experience in Pharmaceutical industry, with relevant experience in pharmacovigilance/ quality/compliance
* Must have experience with case processing and case management
* Experience with SOPs, quality documentation and audits/inspections
* Able to conduct PV Self-Assessments and manage PSMF
* Comfortable using information systems
* As individual you are: pro-active, organized, an excellent communicator in English and Dutch, able to manage multiple projects simultaneously and support other colleagues

Interested? Or know someone who might be? Apply via LinkedIn or send your CV in Word format to: [email protected] before 24th June 2020.

Please note that only shortlisted candidates will be contacted.

Pharmacovigilance, Quality, Compliance, Drug Safety, Pharmaceutical, Biotechnology, Medical Device, Freelance, Contractor, Leiden, Netherlands, Zuid Holland, PV, Affiliate, Vendor Management, Audit, Inspection, SOPs, CAPAs, Case Processing

Disclaimer

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age and experience, and we confirm that we are happy to accept applications from persons of any age and experience for this role.