Regulatory Affairspharmacovigilance Pharmacist

Airgas; Gauteng; On-site; ZAR 350 000 - 500 000; Full time

Job summary

A leading chemical company in South Africa, Gauteng, is seeking a Regulatory Affairs/Pharmacovigilance Pharmacist to manage regulatory compliance processes. The role involves preparing SAHPRA dossiers, monitoring regulatory changes, and ensuring GxP compliance. Ideal candidates will have a Bachelor's degree in Pharmacy and 3–5 years of relevant experience, including strong knowledge of SAHPRA regulations.

Qualifications

• 3–5 years' experience in regulatory affairs, QA, or pharmacovigilance.
• Strong knowledge of SAHPRA, ISO, WHO GxP/GVP, GMP/GDP standards and regulations.

Responsibilities

• 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.
• Collect, assess, and report adverse events.
• Draft and maintain Risk Management Plans and PSUR's.
• Ensure GxP compliance.

Skills

Regulatory Affairs

Pharmacovigilance

GxP Compliance

Education

Bachelor of Pharmacy (BPharm) or equivalent

Registration with the South African Pharmacy Council

Job description

Regulatory Affairs/Pharmacovigilance Pharmacist

Posted today

Job Description

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 Subsidiary's 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)

Responsibilities

• 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.
• Pharmacovigilance
• Collect, assess, and report adverse events.
• Maintain pharmacovigilance systems.
• Draft and maintain Risk Management Plans and PSUR's.
• Responsible for pharmacovigilance audits (Self inspection, ALLISA audit and external audit).
• Communicate safety updates to stakeholders.
• Quality & Compliance
• Ensure GxP compliance.
• Document control, deviation handling, CAPA.
• Provide training on regulatory/PV requirements.
• Collaborate with QA, production, and distribution teams.

Qualifications

• Bachelor of Pharmacy (BPharm) or equivalent.
• Registration with the South African Pharmacy Council.
• 3–5 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.

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