Pharmacovigilance Specialist: Drug Safety & Reporting

Placements24; Queenstown; Vor Ort; NZD 51.000 - 80.000; Vollzeit

Benefits dieser Stelle

Medical aid

Retirement fund

Professional development

Collaborative team

Global health impact

Paid time off

Career growth

Wellness programs

Performance reviews

Parking

Zusammenfassung

Placements24 is seeking a Pharmacovigilance Specialist to join a drug safety team in Queenstown, SA. You will monitor, collect, assess, and report adverse events to ensure patient safety and regulatory compliance, collaborating with medical, regulatory, and clinical teams.

Ideal candidates have a strong pharmacovigilance background, experience with Argus/ArisG, and excellent communication and analytical skills to manage multiple safety cases and regulatory timelines.

Qualifikationen

• Bachelor's degree in Pharmacy, Nursing, Medicine, or related field.
• Minimum 3 years of pharmacovigilance or drug safety experience.
• Strong understanding of pharmacovigilance principles and regulatory reporting requirements.
• Proficiency with pharmacovigilance databases (Argus, ArisG).
• Excellent written and verbal communication skills.
• Attention to detail and strong organizational skills.
• Ability to work independently and in a multidisciplinary team.
• Proficiency in Microsoft Office Suite.

Aufgaben

• Collect, process, and document adverse event reports from multiple sources.
• Assess seriousness and expectedness of reported events.
• Enter and maintain safety data in the pharmacovigilance database.
• Generate and submit regulatory safety reports (PBRERs, DSURs, expedited reports).
• Liaise with healthcare professionals, regulators, and internal stakeholders about safety matters.
• Contribute to safety documents such as Investigator's Brochures and Risk Management Plans.
• Participate in safety surveillance and signal detection processes.
• Ensure compliance with global pharmacovigilance regulations and company policies.
• Support audits and inspections related to pharmacovigilance.
• Stay updated on pharmacovigilance guidelines and scientific advancements.

Kenntnisse

Pharmacovigilance principles

Regulatory requirements

MedDRA/WHO-ART coding

Safety data analysis

Written and verbal communication

Detail-oriented

Independent work

Microsoft Office

Ausbildung

Bachelor's degree in Pharmacy/Nursing/Medicine or related field

Tools

Pharmacovigilance databases (Argus, ArisG)

Jobbeschreibung

Placements24 is seeking a Pharmacovigilance Specialist to join a drug safety team in Queenstown, SA. You will monitor, collect, assess, and report adverse events to ensure patient safety and regulatory compliance, collaborating with medical, regulatory, and clinical teams.

Ideal candidates have a strong pharmacovigilance background, experience with Argus/ArisG, and excellent communication and analytical skills to manage multiple safety cases and regulatory timelines.