Pharmacovigilance Officer

Placements24; Southampton; Remote; GBP 40,000 - 65,000; Full time

Benefits offered by this job

Flexible remote work

Job summary

Placements24 seeks a Pharmacovigilance Officer to join a respected pharmaceutical organization. This fully remote role focuses on monitoring, processing, and reporting adverse events, ensuring global safety compliance.

You will manage safety data, contribute to PSURs, liaise with regulators, and maintain pharmacovigilance procedures while working independently from a remote environment. 3+ years in PV and strong analytical skills are expected.

Qualifications

• Bachelor's or master's degree in Pharmacy, Nursing, Medicine, or life science field.
• 3+ years in pharmacovigilance, drug safety, or clinical safety.
• Strong knowledge of global pharmacovigilance regulations and guidelines (ICH-GCP, CIOMS).
• Experience with adverse event case processing and reporting.

Responsibilities

• Process, evaluate, and report AE/ADR cases within regulatory timelines.
• Ensure safety data accuracy and quality.
• Perform literature searches for safety signals.
• Assist PSURs and other regulatory safety documents.
• Develop and maintain PV procedures and SOPs.
• Liaise with regulators, healthcare professionals, and internal teams.
• Attend safety review meetings and support risk management planning.
• Identify potential safety signals and assess them.
• Ensure compliance with local and international PV regulations.
• Maintain safety databases and records.

Skills

Analytical skills

Attention to detail

Verbal communication

Written communication

Remote work self-management

Education

Bachelor's or Master's degree in Pharmacy/Nursing/Medicine or life sciences

Tools

Pharmacovigilance software

Job description

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.