Senior Pharmacovigilance Officer

Placements24; Klerksdorp; In loco; ZAR 600.000 - 900.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Retirement contributions

Professional development opportunities

Descrizione del lavoro

Placements24 in Klerksdorp is seeking a Senior Pharmacovigilance Officer to join our safety surveillance team. The role focuses on post-marketing safety, ensuring patient safety and regulatory compliance in all activities.

You will manage adverse event processing, PSURs/PBRERs submissions, signal detection, risk management, and cross-functional coordination with Medical Affairs and Regulatory. A strong pharmacovigilance background is essential.

Competenze

• Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Knowledge of pharmacovigilance principles, adverse event reporting, and regulatory requirements (e.g., GVP, FDA).
• Experience with safety databases and case processing (Argus, ARISg).
• Familiarity with signal detection methodologies and risk management strategies.
• Strong analytical and critical thinking skills.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities.
• Attention to detail and patient safety.
• Proficiency in relevant software applications.

Mansioni

• Manage and process adverse event reports in accordance with regulatory requirements and SOPs.
• Perform initial assessment of adverse event reports for completeness, accuracy, and seriousness.
• Conduct literature searches for potential safety signals and new information.
• Contribute to development and implementation of risk management plans (RMPs).
• Prepare and submit periodic safety update reports (PSURs/PBRERs) to health authorities.
• Participate in signal detection activities and contribute to safety review meetings.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Maintain accurate and up-to-date pharmacovigilance databases.
• Train and mentor junior pharmacovigilance staff.
• Liaise with internal departments and external stakeholders on safety matters.

Conoscenze

Analytical thinking

Critical thinking

Written communication

Verbal communication

Independent worker

Multitasking

Attention to detail

Formazione

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

Strumenti

Argus

ARISg

Descrizione del lavoro

About the Role

Our client, a prominent pharmaceutical company, is seeking a dedicated and experienced Senior Pharmacovigilance Officer to join their safety surveillance team in Klerksdorp . This role is crucial for monitoring the safety of our pharmaceutical products post-marketing, ensuring patient safety, and maintaining regulatory compliance. The Senior Pharmacovigilance Officer will be responsible for case processing, signal detection, risk management activities, and contributing to regulatory reporting. The ideal candidate will possess a strong understanding of pharmacovigilance principles, adverse event reporting systems, and relevant global regulations. This is an excellent opportunity to contribute to patient safety initiatives within a dynamic pharmaceutical environment. You will work closely with regulatory affairs and medical affairs to ensure comprehensive safety monitoring.

Key Responsibilities

Manage and process adverse event reports in accordance with regulatory requirements and company SOPs. Perform initial assessment of adverse event reports for completeness, accuracy, and seriousness. Conduct literature searches for potential safety signals and new information. Contribute to the development and implementation of risk management plans (RMPs). Prepare and submit periodic safety update reports (PSURs/PBRERs) to health authorities. Participate in signal detection activities and contribute to safety review meetings. Ensure compliance with global pharmacovigilance regulations and guidelines. Maintain accurate and up-to-date pharmacovigilance databases. Train and mentor junior pharmacovigilance staff. Liaise with internal departments (Medical Affairs, Regulatory Affairs, Clinical Operations) and external stakeholders (healthcare professionals, regulatory agencies) on safety matters.

Requirements

Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related field. A minimum of 5 years of experience in pharmacovigilance or drug safety. In-depth knowledge of pharmacovigilance principles, adverse event reporting, and regulatory requirements (e.g., GVP, FDA regulations). Experience with safety databases (e.g., Argus, ARISg) and case processing. Familiarity with signal detection methodologies and risk management strategies. Strong analytical and critical thinking skills. Excellent written and verbal communication skills. Ability to work independently and manage multiple priorities effectively. Attention to detail and a commitment to patient safety. Proficiency in relevant software applications.

Benefits

Our client offers a competitive salary and benefits package, including comprehensive health insurance, retirement contributions, and opportunities for professional development. This role is based in Klerksdorp , offering a stable and engaging work environment. We are committed to fostering a culture of safety and continuous learning. Joining our team means contributing to a company dedicated to ensuring the safety and efficacy of pharmaceutical products. We provide ongoing training to keep you at the forefront of pharmacovigilance practices. Enjoy a supportive team atmosphere and the chance to make a tangible impact on public health. Participate in industry-specific training and conferences to enhance your expertise.