Pharmacovigilance & Regulatory Affairs Lead

Zuellig Pharma; Shah Alam; Presencial; MYR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Inclusive environment

Career growth

Total Rewards

Regional exposure

Descripción de la vacante

Zuellig Pharma Malaysia seeks a Regulatory Pharmacovigilance Associate to ensure safety reporting complies with NPRA and international PV guidelines. You will act as the liaison for pharmacovigilance matters with NPRA, clients, and healthcare professionals.

You will guide the Regulatory Affairs Team on regulatory changes, maintain ICSR timelines, and help prepare safety documentation to meet service levels. A pharmacy degree and familiarity with PV principles are required or preferred.

Formación

• Bachelor's degree in Pharmacy or equivalent and registered pharmacist preferred.
• Familiarity with pharmacovigilance principles and local PV regulations.
• Excellent written and verbal communication; strong documentation practices.

Responsabilidades

• Ensure safety reporting aligns with local NPRA and international PV guidelines.
• Liaise with NPRA, regulatory agencies, and clients on pharmacovigilance matters.
• Guide Regulatory Affairs Team on regulatory policy changes affecting PV.
• Support inspections, audits, and other duties as requested by Head of Regulatory.

Conocimientos

PV knowledge

Regulatory affairs

Documentation

Communication

Attention to detail

NPRA familiarity

Educación

Bachelor's degree in Pharmacy

Registered Pharmacist

Herramientas

Veeva Systems

MS Office

Descripción del empleo

Zuellig Pharma Malaysia seeks a Regulatory Pharmacovigilance Associate to ensure safety reporting complies with NPRA and international PV guidelines. You will act as the liaison for pharmacovigilance matters with NPRA, clients, and healthcare professionals.

You will guide the Regulatory Affairs Team on regulatory changes, maintain ICSR timelines, and help prepare safety documentation to meet service levels. A pharmacy degree and familiarity with PV principles are required or preferred.