ACTG-CRO / recrute

 Senior Pharmacovigilance Officer

based in Tunis:

We are looking for a Senior Pharmacovigilance Officer to work for outsourcing contracts within our office in Tunis (Tunisia) for one of our Partners.

  • Location: Tunis
  • Duration: 12 Months (minimum but reconductible)
  • Type: Fulltime employee temporary contract 
  • Seniority level: Senior (4+ years in pharma industry or consulting for pharma)

Role: 

The PV Senior Consultant is in charge of following or assisting on projects with Pharma, Medical Devices or Cosmetics Companies. Projects may include the following tasks, based on the candidate specific experience (see SKILLS):

  • Preparation or review of Policies, SOPs and WIs for pharmacovigilance
  • Preparation and on-site execution of GVP audits as lead auditor
  • Preparation or review of GVP audit reports and subsequent CAPA review
  • Preparation or review of DPIAs and documentation connected to the EU GDPR applied to the pharmacovigilance and clinical research areas
  • Preparation or review of CSV documentation for systems in use in pharmacovigilance
  • Execution or support to execution of OQ and PQ tests
  • CSV documentation on-paper audits
  • Preparation and on-site execution of PV software vendors audits

 

Skills required: 

  • GVP Audits
  • PV Quality Assurance and Quality Systems oversight

Either in:

  • Computer Systems Validation

Having experience in all these areas will be a relevant added value.

 

Additional Required skills:

  • GVP Knowledge
  • Good written and spoken English
  • MS Outlook, Word, Excel
  • Good communication and personal organisation
  • Flexibility

Optional skills:

  • GAMP Knowledge
  • EU GDPR Knowledge
  • PV Databases knowledge (ARISg, Argus Safety…)
  • GANTT Knowledge

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Clinical Research Associate in Sudan: 

CRA will set up, monitor and close-down clinical studies. As a CRA, you will conduct site monitoring responsibilities for Clinical trials, according to ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring and Close-out visits. Report to the Manager.

 

Skills required:

  • Scientific background +++
  • Ability to build trust with site personnel and communicate properly +++
  • Fluent in Arabic and English +++
  • Rigorous and organized +++
  • Hard worker and eager to learn +++
  • Open for Junior CRA

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Please send us your application with two references at

with the position you apply for in the subject of your email.

An application includes a cover letter and a CV with two references.