• 10 Av H Bourguiba Imm Zephyr B 3-1 , 2080 Ariana ,Tunisie
  • 9h-16h, du lundi au vendredi

Senior Pharmacovigilance (PV) Officer

  • Full Time
  • Tunis

Site ACTG-CRO

ACTG-CRO (Africa Clinical Trials Group) est une Organisation à Contrat de Recherche (CRO) basée à Tunis (Tunisie), qui fournit des services CRO à travers l’Afrique en assistant partiellement ou totalement les sponsors* locaux ou internationaux dans toutes les phases de conception, de réalisation, gestion, exécution et analyse de leurs projets d’études : Access Program (Tunisie), études interventionnelles et non-interventionnelles, pré- et post-AMM, études de bioéquivalence.

Description de l’emploi

The PV Senior Officier 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)

Job Function: Senior Pharmacovigilance Officer

Type: Full-time employee temporary contract

Duration: 12 Months (minimum but reconductible)

Seniority Level: Senior (4+ years in pharma industry or consulting for pharma)

  • 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

Exigences de l’emploi

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

If interested, please send us a cover letter and CV at hr@actg-cro.com with the reference: “SPVO_Tunis” in the subject of the email.

Pour postuler, envoyez votre CV et votre lettre de motivation par e-mail à hr@actg-cro.com