Senior Pharmacovigilance Specialist - Drug Safety

Placements24; Upington; Hybride; ZAR 900 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Hybrid working model

Private medical aid

Retirement fund and performance-based;

Résumé du poste

Placements24 is seeking a Senior Pharmacovigilance Specialist to join our drug safety team in Upington, Northern Cape. You will manage adverse event data, contribute to signal detection, and support regulatory reporting to ensure patient safety across the portfolio.

The role requires at least 5 years in pharmacovigilance, a life-science degree, and strong knowledge of global safety regulations. A hybrid work model and opportunities for professional development are offered.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Medicine, or related life science.
• Minimum 5 years of pharmacovigilance or drug safety experience.
• Strong knowledge of global safety regulations (ICH, GVP).
• Experience with adverse event reporting systems and safety databases.
• Experience with signal detection and aggregate reporting.

Responsabilités

• Collect, process, and assess adverse event reports from multiple sources.
• Perform medical case reviews and determine seriousness and causality.
• Prepare and submit safety reports (PBRERs, DSURs) to regulatory authorities.
• Collaborate with Medical Affairs, Regulatory, and Clinical Development on safety.
• Ensure compliance with global pharmacovigilance regulations and company policies.

Connaissances

Adverse event management

Pharmacovigilance

Regulatory reporting

Data analysis

Communication skills

Formation

Bachelor's degree in Pharmacy/Nursing/Medicine or life sciences

Master's degree or equivalent

Outils

Safety databases

AE reporting systems

Description du poste

About the Role

Our client, a globally recognized pharmaceutical company, is seeking a Senior Pharmacovigilance Specialist to join their dedicated drug safety team. This critical role, based in Upington, Northern Cape , is responsible for ensuring the safety of patients by managing and monitoring adverse event data for pharmaceutical products. The Senior Specialist will play a key role in signal detection, risk assessment, and regulatory reporting, contributing to the ongoing safety profile of the company's portfolio. This position offers a challenging and rewarding opportunity to contribute to patient safety and regulatory compliance within the pharmaceutical industry, working with a diverse range of therapeutic areas.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Perform medical case reviews and determine the seriousness and causality of adverse events.
• Contribute to signal detection activities, identifying potential safety issues proactively.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities.
• Ensure compliance with global pharmacovigilance regulations and company policies.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) on safety-related matters.
• Participate in the development and updating of company safety procedures and training materials.
• Support safety database management and data quality assurance activities.
• Respond to regulatory authority inquiries regarding product safety.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related life science discipline.
• A Master's degree or equivalent advanced qualification is preferred.
• Minimum of 5 years of experience in pharmacovigilance or drug safety, with a strong understanding of global safety regulations.
• Proficiency in adverse event reporting systems and safety databases.
• Experience with signal detection methodologies and aggregate reporting is essential.
• Solid understanding of clinical trial processes and post-marketing surveillance.
• Excellent analytical skills, attention to detail, and ability to make sound scientific judgments.
• Strong written and verbal communication skills, with the ability to articulate complex safety information clearly.
• Ability to work effectively both independently and as part of a collaborative team.
• Familiarity with ICH guidelines related to pharmacovigilance.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive benefits package including private medical aid, a retirement fund, and performance-based bonuses.
• Excellent opportunities for professional development, ongoing training, and support for relevant certifications.
• Hybrid working model, allowing for flexibility between office-based tasks and remote work, balanced with the advantages of living in the unique landscape of Upington.
• Supportive and dynamic work environment focused on scientific rigor and patient well-being.

We are committed to diversity and inclusion.