Remote Senior Pharmacovigilance Scientist — Safety & Signals

Placements24; Stellenbosch; Hybrid; ZAR 1.200.000 - 1.600.000; Vollzeit

Zusammenfassung

Placements24 is seeking a Senior Pharmacovigilance Scientist for a fully remote position with a global pharmaceutical client. The role focuses on collecting, assessing, and reporting adverse event data across multiple markets to ensure product safety and regulatory compliance.

Required are 5+ years in pharmacovigilance, a Master’s degree or higher, and strong analytical and communication skills suitable for remote collaboration. Proficiency with safety databases (Argus/ArisG) is advantageous.

Qualifikationen

• Master's or Doctoral degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Minimum of 5 years of hands-on experience in pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA) and reporting requirements.
• Experience with safety database systems (e.g., Argus, ArisG) and case processing.
• Proficiency in signal detection methodologies and aggregate data reporting.
• Strong analytical skills, critical thinking, and problem-solving abilities.
• Excellent written and verbal communication skills, essential for remote collaboration.
• Ability to work independently, manage time effectively, and meet strict deadlines in a remote work environment.
• Previous experience related to the Stellenbosch, Western Cape region, while not mandatory for this remote role, indicates familiarity with local regulatory nuances.

Aufgaben

• Process, evaluate, and report adverse event cases in compliance with global regulatory requirements and company procedures.
• Perform safety data review, trend analysis, and signal detection activities.
• Contribute to the preparation and submission of periodic safety update reports (PSURs/PBRERs) and other regulatory safety documents.
• Collaborate with internal departments (Clinical, Regulatory Affairs, Medical Affairs) and external partners on safety-related matters.
• Participate in the development and maintenance of safety databases and pharmacovigilance systems.
• Provide input into the safety sections of clinical trial protocols, investigator brochures, and informed consent forms.
• Stay updated on global pharmacovigilance regulations, guidelines, and best practices.
• Contribute to risk management plan development and implementation.
• Train and mentor junior pharmacovigilance staff as needed.

Kenntnisse

Pharmacovigilance

Safety data review

Signal detection

Regulatory compliance

Medical writing

Ausbildung

Master's degree in Pharmacy/Medicine

Tools

Argus

ArisG

Jobbeschreibung

Placements24 is seeking a Senior Pharmacovigilance Scientist for a fully remote position with a global pharmaceutical client. The role focuses on collecting, assessing, and reporting adverse event data across multiple markets to ensure product safety and regulatory compliance.

Required are 5+ years in pharmacovigilance, a Master’s degree or higher, and strong analytical and communication skills suitable for remote collaboration. Proficiency with safety databases (Argus/ArisG) is advantageous.