Senior Pharmacovigilance Specialist - Global Safety

Placements24; Pretoria; Hybrid; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Bonus potential

Health insurance

Dental coverage

Vision coverage

PTO

Retirement plan

Home office allowance

Professional training

Zusammenfassung

Placements24 seeks a Senior Pharmacovigilance Specialist to join a remote-first safety surveillance team. You will monitor, evaluate, and report adverse events for marketed products worldwide, ensuring patient safety and regulatory compliance.

Ideal candidates have 4+ years in pharmacovigilance, solid knowledge of FDA/EMA/SAHPRA regulations, and experience with safety databases and PSURs. This role offers global collaboration and significant impact on drug safety.

Qualifikationen

• Bachelor's or Master's degree in a healthcare-related field (e.g., Pharmacy, Nursing, Life Sciences).
• Minimum of 4 years in pharmacovigilance or drug safety.
• Strong knowledge of global pharmacovigilance regulations (FDA, EMA, SAHPRA).
• Experience with safety databases and AE reporting systems.

Aufgaben

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely and accurate reporting to regulatory authorities worldwide.
• Conduct signal detection to identify new safety concerns.
• Assist in PSURs and Risk Management Plans.
• Collaborate with internal and external stakeholders on safety matters.
• Participate in regulatory inspections and respond to safety inquiries.
• Maintain and update safety databases with accuracy.

Kenntnisse

Pharmacovigilance

Regulatory knowledge

Data analysis

Communication

Remote work

Ausbildung

Bachelor's or Master's in healthcare field

Jobbeschreibung

About the Role

Our client, a global leader in pharmaceutical innovation, is seeking a highly skilled and dedicated Senior Pharmacovigilance Specialist to join their remote-first safety surveillance team. This is a critical role responsible for monitoring and evaluating the safety of our marketed pharmaceutical products worldwide. You will be instrumental in ensuring patient safety by meticulously collecting, assessing, and reporting adverse event data. This fully remote position allows you to contribute your expertise from anywhere, collaborating with international teams and driving best practices in drug safety. The ideal candidate possesses a strong understanding of global regulatory requirements for pharmacovigilance and a keen eye for detail. This role offers a significant opportunity to impact patient well-being on a global scale through rigorous safety monitoring and reporting. You will be a key player in maintaining the safety profile of our innovative medicines.

Key Responsibilities

• Collect, process, and evaluate adverse event (AE) reports from various sources, including spontaneous reports, literature, and clinical trials.
• Ensure timely and accurate reporting of safety information to regulatory authorities worldwide in compliance with global regulations.
• Conduct signal detection activities to identify potential new safety concerns related to our products.
• Contribute to the preparation of safety documents, such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Collaborate with internal departments (e.g., Clinical, Medical Affairs, Regulatory) and external stakeholders on safety-related matters.
• Participate in regulatory authority inspections and respond to safety inquiries.
• Maintain and update safety databases with accurate and complete information.
• Stay current with evolving pharmacovigilance regulations and guidelines globally.
• Assist in the development and implementation of pharmacovigilance policies and procedures.

Requirements

• Bachelor's or Master's degree in a healthcare-related field (e.g., Pharmacy, Nursing, Life Sciences).
• A minimum of 4 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and AE reporting systems.
• Proficiency in signal detection methodologies and risk assessment.
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to clearly articulate complex safety information.
• Ability to work independently in a remote setting and manage multiple priorities effectively.
• Detail-oriented with a strong commitment to accuracy and compliance.

Benefits

• Competitive salary package and potential for bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and sick leave.
• Retirement savings plan.
• Home office setup allowance.
• Opportunities for professional growth and specialized training in pharmacovigilance.
• Work remotely with a globally recognized pharmaceutical company.
• Make a tangible contribution to patient safety worldwide.