ACTG-CRO / recrute CDD

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

The Secretary/Executive Assistant provides secretarial services to the executive management, assisting with administrative management and organization, manages appointments, agenda, organizes trips and prepares meetings, welcomes customers, monitors activity, classifies and archives documents, captures digital documents. Discretion and organization are essential qualities required for this job.

Roles:

• Daily administrative management
• Mail processing and file monitoring
• Phone Calls management
• Organization of management meetings and agendas
• Assistance in the administrative management of staff
• Accounting management (classification + entry)
• Reception modalities

Skills required:

• Writing technique (flawless spelling) and synthesis
• Sense of organization
• Ability to prioritize information
• Dynamism and discretion at the same time
• Mandatory: mastering office software, including the Office pack
• Perfect English, French and Arabic languages ​​is Mandatory (Spoken, Written) and all other languages ​​is an asset
• Eager to learn