Senior Pharmacovigilance Specialist

Placements24; Southampton; Sur place; GBP 32 000 - 45 000; Plein temps

Résumé du poste

Placements24 is seeking a highly skilled Senior Pharmacovigilance Specialist to join their safety surveillance team in Randburg. You will collect, assess, and report adverse event data, and ensure ongoing compliance with global regulatory requirements.

Candidates should hold a degree in Pharmacy, Nursing, Medicine, or a related field and have 4–6 years of pharmacovigilance or drug safety experience, with strong analytical and communication skills and a track record in risk management and PSURs.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related healthcare/life science field.
• Minimum of 4-6 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of pharmacovigilance regulations and guidelines (e.g., GVP, CIOMS, FDA, EMA).
• Experience with safety databases (e.g., Argus, ARISg) and adverse event reporting systems.
• Strong analytical, investigative, and problem-solving skills.
• Excellent written and verbal communication skills.

Responsabilités

• Collect, process, and assess adverse event reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities and other stakeholders.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Participate in the development and implementation of risk management plans (RMPs).
• Maintain and update safety databases, ensuring data integrity and compliance.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs).

Connaissances

Pharmacovigilance

Regulatory compliance

Data analysis

Adverse event reporting

Communication skills

Formation

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

Outils

Argus

ARISg

Description du poste

About the Role

Our client is seeking a highly skilled and experienced Senior Pharmacovigilance Specialist to join their safety surveillance team in Randburg . This role is essential for ensuring the ongoing safety and monitoring of pharmaceutical products post-market. You will be responsible for collecting, assessing, and reporting adverse event data, maintaining compliance with global regulatory requirements, and contributing to risk management strategies. The ideal candidate possesses a deep understanding of pharmacovigilance principles, excellent analytical skills, and the ability to manage multiple priorities in a dynamic environment. Your contribution will be vital in protecting public health and ensuring the continued safe use of our client's medicines.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities and other stakeholders.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Participate in the development and implementation of risk management plans (RMPs).
• Maintain and update safety databases, ensuring data integrity and compliance.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs).

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related healthcare/life science field.
• Minimum of 4-6 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of pharmacovigilance regulations and guidelines (e.g., GVP, CIOMS, FDA, EMA).
• Experience with safety databases (e.g., Argus, ARISg) and adverse event reporting systems.
• Strong analytical, investigative, and problem-solving skills.
• Excellent written and verbal communication skills.

Benefits

• Competitive annual salary with potential for performance-based rewards.
• Comprehensive health, dental, and vision insurance.
• Opportunities for specialized training in pharmacovigilance and drug safety.
• Work within a well-established pharmaceutical company dedicated to patient safety.
• Generous annual leave and retirement benefits package.