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Regulatory AffairsPharmacovigilance Pharmacist

Regulatory AffairsPharmacovigilance Pharmacist

Air LiquideAlberton, Gauteng, South Africa
17 days ago
Job description

Overview

How will you CONTRIBUTE and GROW

Provide assistance in order to develop implement and / or manage the Industrial Regulatory compliance process within a specific scope in accordance with the group Procedure and / or corresponding Subsidiarys procedures (including : Healthcare Regulatory Affairs & Pharmacovigilance).

INCLUDE : jobs requiring a technical knowledge on the topic

EXCLUDE : jobs requiring a pure legal expertise like a lawyer specialized in pharmaceutical law (they should be coded in the Job Family Legal & Intellectual Property in the Group Job Regulatory Compliance Counsel)

1. Regulatory Affairs

  • Prepare submit and maintain SAHPRA dossiers.
  • Monitor regulatory changes and provide regulatory intelligence.
  • Support in inspections and audits.
  • Coordinate responses to authorities.
  • Maintain a registration database.

2. Pharmacovigilance

  • Collect assess and report adverse events.
  • Maintain pharmacovigilance systems.
  • Draft and maintain Risk Management Plans and PSURs.
  • Responsible for pharmacovigilance audits (Self inspection ALLISA audit and external audit).
  • Communicate safety updates to stakeholders.

    • 3. Quality & Compliance

  • Ensure GxP compliance.
  • Document control deviation handling CAPA.
  • Provide training on regulatory / PV requirements.
  • Collaborate with QA production and distribution teams.

    • Are you a MATCH

  • Bachelor of Pharmacy (BPharm) or equivalent.
  • Registration with the South African Pharmacy Council.
  • 35 years experience in regulatory affairs QA or pharmacovigilance.
  • Strong knowledge of SAHPRA ISO WHO GxP / GVP GMP / GDP standards and regulations.

    • Our Differences make our Performance

    At Air Liquide we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees our customers patients community stakeholders and cultures across the world.

    We welcome and consider applications from all qualified applicants regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent both individually and collectively and it helps foster our ability to innovate by living our fundamentals acting for our success and creating an engaging environment in a changing world.

    Key Skills

    Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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    Pharmacist • Alberton, Gauteng, South Africa