Senior Pharmacovigilance Specialist

Placements24; Gqeberha; Presencial; ZAR 900 000 - 1 200 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary with annual bonus

Medical, dental, and vision insurance

Retirement plan with company matching

Generous PTO and sick leave

Resumo da oferta

Placements24 is assisting a prominent pharmaceutical leader in Port Elizabeth, Eastern Cape, ZA, to recruit a Senior Pharmacovigilance Specialist. You will lead safety signal evaluation, adverse event processing, and regulatory submissions to SAHPRA and global authorities.

The role requires a degree in Pharmacy/Nursing/Life Sciences, 5+ years in PV, and strong data management skills. You will collaborate with global safety teams in a patient-focused safety environment.

Qualificações

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field.
• Minimum 5 years' pharmacovigilance or drug safety experience.
• Knowledge of global pharmacovigilance regulations (FDA, EMA, SAHPRA).
• Experience with adverse event case processing and safety databases.
• Strong analytical and communication skills.

Responsabilidades

• Collect, process, and document adverse event reports from various sources.
• Initial assessment of adverse event reports for completeness and accuracy.
• Literature reviews to identify potential safety signals and new information.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs).
• Contribute to development and implementation of risk management plans (RMPs).
• Ensure compliance with global and local pharmacovigilance regulations.
• Liaise with internal/external stakeholders regarding safety matters.
• Participate in safety database management and QA activities.
• Assist in safety responses to regulatory queries.
• Maintain up-to-date knowledge of pharmacovigilance best practices.

Conhecimentos

Pharmacovigilance

Regulatory knowledge

AE case processing

Analytical thinking

Communication

Formação académica

Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field

Ferramentas

Argus

ARISg

Descrição da oferta de emprego

About the Role

Our client, a prominent leader in the **Pharmaceutical** sector, is seeking a dedicated Senior Pharmacovigilance Specialist to join their critical safety monitoring team in Port Elizabeth, Eastern Cape, ZA. This role is essential for ensuring the safety of patients by meticulously collecting, evaluating, and reporting adverse events associated with our client's medicinal products. The ideal candidate will possess a strong understanding of pharmacovigilance principles, regulatory requirements, and data management systems. You will be responsible for maintaining high standards of safety reporting, contributing to risk management activities, and collaborating with global safety teams. This position offers a meaningful opportunity to contribute to patient well-being and uphold the integrity of **Pharmaceutical** products within a supportive and professional setting in Port Elizabeth. Join us and play a vital role in ensuring drug safety within the **Eastern Cape, ZA** region.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources.
• Perform initial assessment of adverse event reports for completeness and accuracy.
• Conduct literature reviews to identify potential safety signals and new safety information.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities.
• Contribute to the development and implementation of risk management plans (RMPs).
• Ensure compliance with global and local pharmacovigilance regulations and guidelines.
• Liaise with internal departments (e.g., Medical Affairs, Clinical Operations) and external stakeholders regarding safety matters.
• Participate in safety database management and quality control activities.
• Assist in the preparation of safety-related responses to regulatory authority queries.
• Maintain up-to-date knowledge of pharmacovigilance best practices and regulatory changes.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA).
• Experience with adverse event case processing and safety database systems (e.g., Argus, ARISg).
• Familiarity with aggregate report preparation and regulatory submissions.
• Strong analytical and critical thinking skills.
• Excellent attention to detail and organizational abilities.
• Effective written and verbal communication skills.
• Ability to work independently and as part of a global team.
• Experience within the **Eastern Cape, ZA** healthcare sector is a plus.

Benefits

• Competitive salary package with potential for annual performance bonuses.
• Comprehensive medical, dental, and vision insurance.
• Retirement savings plan with company matching.
• Generous paid time off and sick leave allowances.
• Opportunities for specialized training and professional development in pharmacovigilance.
• Work in a well-established **Pharmaceutical** company with a strong safety focus.
• Supportive team environment at our **Port Elizabeth** location.
• Potential for career progression within the safety and medical affairs functions.