Pharmacovigilance Specialist

Placements24; Waukee (IA); Sur place; USD 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Competitive salary & bonuses

Comprehensive medical & retirement

Specialized PV training

Collaborative work environment

Résumé du poste

Placements24 is seeking a Pharmacovigilance Specialist to join the safety team and monitor the post-market safety of pharmaceutical products. You will collect, assess, and report adverse events, ensuring compliance with global regulatory requirements while contributing to signal detection and risk management initiatives.

The role requires a Bachelor's degree in a healthcare field and at least 3 years of PV or drug safety experience, with strong analytical skills and English proficiency.

Qualifications

• Bachelor's degree in a healthcare field is required.
• Minimum of 3 years' experience in pharmacovigilance or drug safety.
• Solid understanding of global pharmacovigilance regulations and reporting requirements (e.g., ICH E2A, E2B).
• Experience with safety databases and adverse event reporting systems.

Responsabilités

• Collect, process, and document adverse event reports from various sources.
• Assess seriousness and causality of adverse events according to company and regulatory standards.
• Prepare and submit regulatory safety reports within strict timelines.
• Support signal detection activities and contribute to risk management plans.
• Maintain the pharmacovigilance database and ensure data accuracy and completeness.
• Collaborate with internal stakeholders (e.g., Medical, Regulatory) and external partners on safety matters.

Connaissances

Analytical thinking

Attention to detail

English proficiency

Formation

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

Outils

Safety databases

Adverse event reporting systems

Description du poste

About the Role

Our client is seeking a diligent and experienced Pharmacovigilance Specialist to join their dedicated safety team in Paarl . This role is essential for monitoring the safety of our client's pharmaceutical products post-market, ensuring compliance with global regulatory requirements, and protecting patient health. You will be responsible for collecting, assessing, and reporting adverse events, as well as contributing to signal detection and risk management activities. This is a critical position within the pharmaceutical industry , offering the chance to contribute significantly to drug safety and public health.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources.
• Assess seriousness and causality of adverse events according to company and regulatory standards.
• Prepare and submit regulatory safety reports within strict timelines.
• Support signal detection activities and contribute to risk management plans.
• Maintain the pharmacovigilance database and ensure data accuracy and completeness.
• Collaborate with internal stakeholders (e.g., Medical, Regulatory) and external partners on safety matters.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Solid understanding of global pharmacovigilance regulations and reporting requirements (e.g., ICH E2A, E2B).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and critical thinking skills with excellent attention to detail.
• Proficiency in English, with excellent written and verbal communication skills.

Benefits

• Competitive annual salary and potential for bonuses.
• Comprehensive medical and retirement benefits.
• Opportunities for specialized training in pharmacovigilance and drug safety.
• A collaborative and supportive work environment.
• Contribution to ensuring the safety of pharmaceutical products.