Senior Pharmacovigilance Scientist

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

About the Role

Our client, a global leader in pharmaceutical innovation, is actively seeking a highly experienced Senior Pharmacovigilance Scientist for a fully remote position. This role will focus on ensuring the safety of our marketed products and investigational drugs by meticulously collecting, assessing, and reporting adverse event data. Operating remotely, you will play a crucial part in safeguarding public health and maintaining regulatory compliance across multiple markets. Your expertise will be vital in identifying and mitigating potential safety risks associated with our pharmaceutical offerings.

Key Responsibilities

• 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.

Requirements

• 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.

Benefits

This is a unique opportunity to join a world-class pharmaceutical company in a fully remote capacity. Our client offers an attractive salary, excellent benefits including comprehensive medical coverage, retirement savings plans, generous paid time off, and significant opportunities for professional growth and skill development. You will be part of a dedicated global team committed to ensuring patient safety.