About the Role
Our client, a respected pharmaceutical organization, is seeking a dedicated and vigilant Pharmacovigilance Officer to join their safety team. This role is a fully remote position, allowing you to contribute to patient safety from anywhere. You will play a critical role in monitoring, detecting, assessing, and preventing adverse effects associated with pharmaceutical products. This position requires a meticulous approach to data analysis, case processing, and regulatory reporting, ensuring compliance with global safety regulations. The ideal candidate possesses a strong understanding of pharmacovigilance principles, excellent analytical skills, and a commitment to upholding the highest standards of patient safety. This is an excellent opportunity for a motivated professional to advance their career in a crucial area of pharmaceutical development and post-market surveillance within a flexible, remote work setting.
Key Responsibilities
- Process, evaluate, and report adverse event (AE) and adverse drug reaction (ADR) cases in compliance with regulatory timelines and standards.
- Ensure the accuracy, completeness, and quality of safety data.
- Perform literature searches for safety signals and emerging issues related to company products.
- Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory safety documents.
- Assist in the development and maintenance of pharmacovigilance procedures and SOPs.
- Liaise with regulatory authorities, healthcare professionals, and internal departments regarding safety matters.
- Participate in safety review meetings and contribute to risk management planning.
- Identify potential safety signals and contribute to their assessment and management.
- Ensure compliance with all relevant local and international pharmacovigilance regulations.
- Maintain accurate and organized safety databases and records.
Requirements
- Bachelor's or Master's degree in Pharmacy, Nursing, Medicine, or a related life science field.
- Minimum of 3 years of experience in pharmacovigilance, drug safety, or clinical safety.
- Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., ICH-GCP, CIOMS).
- Experience with adverse event case processing and reporting.
- Familiarity with safety databases and pharmacovigilance software.
- Strong analytical skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently and manage workload effectively in a remote environment.
- Good organizational and time management skills.
- Proficiency in medical terminology and understanding of drug actions and side effects.
Benefits
Enjoy the ultimate flexibility of a fully remote work arrangement combined with a competitive salary and comprehensive benefits package, including medical, dental, and vision insurance, and retirement plan options. Our client provides ongoing training and professional development opportunities to keep you at the forefront of pharmacovigilance practices. You'll be an integral part of a dedicated team focused on ensuring medication safety. This role in Randburg offers a chance to significantly contribute to public health while enjoying the work-life balance that remote employment provides. Experience a rewarding career where your vigilance directly impacts patient well-being.
#J-18808-Ljbffr
Pharmacovigilance Officer in Southampton employer: Placements24
Our client offers an exceptional remote working environment for Tax Specialists, providing unparalleled flexibility and autonomy while ensuring a competitive salary package and performance bonuses. With a strong focus on continuous professional development, employees are encouraged to grow their expertise in South African tax law, all within a supportive culture that values strategic thinking and collaboration across departments.
