Remote Senior Pharmacovigilance Specialist

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Home office stipend

Continuous professional development

Performance-based bonuses

Job summary

Placements24 is assisting a global pharmaceutical company in finding a Senior Pharmacovigilance Specialist for a fully remote role in South Africa. You will lead adverse event processing, causality assessment, and regulatory reporting to global authorities, ensuring timelines are met.

You will collaborate with cross-functional teams and maintain PV systems, staying current with ICH guidelines and MedDRA terminology, while contributing to safety signal detection and PSURs from a remote setting.

Qualifications

• Bachelor’s degree in Pharmacy, Medicine, Nursing or related field.
• Master’s degree or equivalent advanced qualification preferred.
• Minimum 5 years in pharmacovigilance with AE processing and regulatory reporting.
• Solid knowledge of global PV regulations and guidelines (ICH E2A, E2B, E2C).
• Experience with safety databases (Argus, ArisG) and case processing.
• Strong medical assessment and data evaluation skills.
• Excellent written and verbal communication; meticulous attention to detail.
• Ability to work independently in a remote setting and manage multiple priorities.

Responsibilities

• Manage and process adverse event reports from various sources.
• Conduct medical assessment of adverse events, including causality and seriousness.
• Ensure timely safety reports to regulatory authorities and internal stakeholders.
• Maintain and update PV database with accurate AE information.
• Participate in signal detection activities and evaluate potential safety signals.
• Collaborate with cross-functional teams on safety matters.
• Assist in PSURs and other regulatory safety documents.
• Contribute to development and maintenance of PV SOPs and training materials.
• Stay current with global PV regulations and best practices.
• Support audits and inspections related to PV activities.

Skills

Pharmacovigilance

Adverse event processing

Regulatory reporting

Medical assessment

Analytical thinking

Communication skills

Independent work

MedDRA

Global PV knowledge

Education

Bachelor's degree in Pharmacy/Medicine/Nursing

Master's degree preferred

Tools

Argus

ArisG

MedDRA

Job description

About the Role

Our client, a distinguished global pharmaceutical company, is seeking a highly experienced and dedicated Remote Senior Pharmacovigilance Specialist to join their safety surveillance team. This is a fully remote position, offering an exceptional opportunity for a seasoned professional to contribute to ensuring patient safety without the need for physical office presence. The successful candidate will be responsible for the collection, assessment, and reporting of adverse event data for pharmaceutical products, ensuring compliance with global regulatory requirements. This role demands a rigorous approach to safety monitoring and a deep understanding of pharmacovigilance principles. Our client is committed to a remote-first work environment, providing the necessary tools and support for distributed teams to excel and maintain the highest standards of patient safety vigilance from anywhere in South Africa.

Key Responsibilities

• Manage and process adverse event reports from various sources (e.g., clinical trials, post-marking surveillance, literature).
• Conduct medical assessment of adverse event reports, including causality assessment and seriousness determination.
• Ensure timely submission of safety reports to regulatory authorities and internal stakeholders in compliance with global timelines (e.g., CIOMS, MedWatch).
• Maintain and update the company's safety database with accurate and complete adverse event information.
• Participate in signal detection activities and contribute to the evaluation of potential safety signals.
• Collaborate with clinical operations, regulatory affairs, medical affairs, and other relevant departments on safety-related matters.
• Assist in the preparation of periodic safety update reports (PSURs) and other regulatory safety documents.
• Contribute to the development and maintenance of pharmacovigilance SOPs and training materials.
• Stay current with global pharmacovigilance regulations and industry best practices.
• Support audits and inspections related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related healthcare/life science field.
• A Master's degree or equivalent advanced qualification is preferred.
• Minimum of 5 years of experience in pharmacovigilance, with a significant portion in adverse event case processing and regulatory reporting.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH E2A, E2B, E2C).
• Proven experience with safety databases (e.g., Argus, ArisG) and case processing.
• Strong medical assessment skills, including the ability to evaluate clinical data for adverse events.
• Excellent analytical, critical thinking, and problem-solving abilities.
• Exceptional written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently, manage multiple priorities effectively, and meet strict deadlines in a remote setting.
• Familiarity with medical terminology and coding conventions (e.g., MedDRA, WHO-DD).
• Experience in signal detection and risk management is a significant advantage.

Benefits

Our client offers a competitive salary commensurate with experience, a comprehensive benefits package including health insurance and retirement planning, and performance-based bonuses. This fully remote position offers unparalleled flexibility and work-life balance. Additional benefits include a dedicated home office stipend, continuous professional development opportunities, and the chance to work with a leading global pharmaceutical company from the comfort of your own home. Join our client's vital safety team and make a direct impact on patient well-being.

• competitive salary commensurate with experience
• a comprehensive benefits package including health insurance and retirement planning
• performance-based bonuses
• a dedicated home office stipend
• continuous professional development opportunities
• the chance to work with a leading global pharmaceutical company from the comfort of your own home