Remote Pharmacovigilance Officer

About the Role

Our client, a globally recognized pharmaceutical leader, is seeking an experienced and dedicated Remote Pharmacovigilance Officer to join their expanding safety surveillance team. This fully remote position is based in Klerksdorp, North West , offering the flexibility to work from anywhere within South Africa. The successful candidate will play a crucial role in monitoring, detecting, and preventing adverse drug reactions, ensuring the safety of patients worldwide. You will be responsible for collecting, assessing, and reporting safety information related to our client's pharmaceutical products. This is an outstanding opportunity for a skilled pharmacovigilance professional to contribute significantly to patient safety from the comfort of their home office.

The role requires meticulous attention to detail, a strong understanding of regulatory requirements, and excellent analytical skills. Work from home in Klerksdorp and make a global impact.

Key Responsibilities

• Collect, review, and assess individual case safety reports (ICSRs) for accuracy and completeness.
• Ensure timely reporting of ICSR to regulatory authorities and other stakeholders according to global deadlines.
• Manage and maintain the pharmacovigilance database, ensuring data integrity.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory submissions.
• Participate in the development and maintenance of pharmacovigilance procedures and guidelines.
• Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs) and external partners on safety-related matters.
• Support safety risk management activities and the development of risk management plans.
• Stay informed about global pharmacovigilance regulations and guidelines.
• Provide training to internal staff and external stakeholders on pharmacovigilance requirements.

Requirements

• Bachelor’s degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, CIOMS, FDA, EMA, SAHPRA).
• Experience with pharmacovigilance databases and safety reporting systems.
• Strong analytical and critical thinking skills, with the ability to assess complex safety data.
• Excellent written and verbal communication skills.
• Proficiency in data entry and management, with meticulous attention to detail.
• Ability to work independently in a remote setting, demonstrating strong self-discipline and time management skills.
• Adaptability to a global and multicultural working environment.
• Proficiency in English; knowledge of other languages is a plus.

Benefits

Our client offers a highly competitive salary, comprehensive remote work benefits, including a home office stipend and excellent health insurance coverage. A generous annual leave policy and opportunities for professional development and global collaboration are provided. You will be part of a forward-thinking organization committed to employee growth and well-being. Work remotely from Klerksdorp and contribute to a global mission.