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Pharmacovigilance Specialist Belgium

Pharmacovigilance Specialist Belgium

  • Location

    Belgium, Belgium

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Angel Gaskin

  • Contact email:

    Angel.Gaskin@volt.eu.com

  • Job ref:

    74826-PHARM-AGK_1564670366

  • Published:

    3 months ago

  • Duration:

    52 weeks

  • Expiry date:

    2019-08-31

  • Start date:

    ASAP

  • Consultant:

    #

I am currently working with a full service CRO that are looking for an experienced PV specialist based in Belgium. This is an outstanding opportunity for any candidate looking to grow their experience and gain invaluable experience. If you currently looking to take the next step which will allow you to boost your career and offer excellent work-life balance at the same time, apply now.

Main Job Tasks and Responsibilities in the country or region of assignment

  • Acting as Clients 24/7 local contact person for pharmacovigilance at local level.

  • Ensuring the survey and monitoring of national pharmacovigilance regulations and notifying changes, if any, on agreed basis.

  • Ensuring successful communication with local Competent Authorities in reasonably timely manner.

  • Ensuring compliance with processes for proper collection, processing, accurate translation, quality control (at least second self-control), documentation, reporting and follow-up of all safety reports for all Client's contractual partner's products within agreed time lines following contractual partner's procedures.

  • Ensuring weekly monitoring of local literature review in relation with Client's contractual partner's products, where applicable.

  • Ensuring immediate notification to all concerned parties of any enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source.

  • Delivering pharmacovigilance training's to Client's personnel, when required.

  • Providing input in local handling, including preparation and submission, of Periodic Safety Update Reports,

  • Risk Management Plans and risk minimisation activities.

  • Ensuring continuous safety profile monitoring, detection of new signals and evaluation, as applicable.

  • Participating in related inspection and/or audits, including post inspection/audit support.

  • Informing Client without delay about any detected non-compliance of local processes.

  • Continuously developing his/her professional and personal skills and participating in pharmacovigilance relevant training's delivered.

  • Following the principles of confidentiality and personal data protection, as applicable.

  • Ensuring compliance with Clients and Clients contractual partners` procedures.


Minimum requirements

  • 2 to 8 year's experience as a Pharmacovigilance Specialist

  • Experience working for a CRO

  • Demonstrate a consistent background

  • BA minimum