Remote Pharmacovigilance Specialist - Signal Detection

Placements24; Bloemfontein; Híbrido; ZAR 600.000 - 900.000; Jornada completa

Descripción de la vacante

Placements24 is seeking a Remote Pharmacovigilance Specialist to join a global safety team in South Africa. You will monitor adverse events, evaluate safety signals, and contribute to PSURs from a remote, flexible setting.

The ideal candidate has a PV background and strong regulatory knowledge, with excellent communication skills and the ability to work independently. This remote-first opportunity offers competitive compensation, comprehensive benefits, and ongoing professional development

Formación

• Minimum 3 years of pharmacovigilance experience.
• Experience with signal detection and evaluation.
• Knowledge of FDA/EMA regulatory requirements.
• Excellent written and verbal communication.

Responsabilidades

• Perform routine surveillance of adverse event databases and literature to identify safety signals.
• Conduct signal evaluations, including data analysis and causality assessment.
• Prepare signal reports and risk-management recommendations.
• Collaborate with Medical Affairs, Regulatory, and R&D.
• Contribute to PSURs and regulatory safety documents.
• Maintain records of PV activities and documentation.
• Support continuous improvement of PV processes.

Conocimientos

PV experience

Signal detection

Data analysis

Regulatory knowledge

Remote work capability

Communication skills

Educación

Bachelor's in Pharmacy/Life Sciences

Herramientas

Safety database systems

Descripción del empleo

About the Role

Our client, a leading global biopharmaceutical company, is seeking a dedicated and detail-oriented Remote Pharmacovigilance Specialist to join their expanding safety surveillance team. This fully remote position allows you to contribute to patient safety from anywhere in South Africa, working on a diverse portfolio of innovative medicines. You will be responsible for the proactive identification, evaluation, and assessment of potential safety signals, playing a crucial role in ensuring the ongoing safety profile of marketed products. The ideal candidate will possess a strong understanding of pharmacovigilance principles, regulatory requirements, and signal detection methodologies. This is an exceptional opportunity to advance your career in drug safety within a supportive, remote-first environment, making a tangible difference in public health by safeguarding patients.

Key Responsibilities

• Perform routine surveillance of adverse event databases and literature to identify potential safety signals.
• Conduct in-depth signal evaluation, including data analysis, risk-benefit assessment, and determination of causality.
• Prepare comprehensive signal reports and recommendations for risk management activities.
• Collaborate with internal stakeholders (e.g., Medical Affairs, Regulatory Affairs, R&D) to discuss and manage identified safety signals.
• Contribute to the preparation and maintenance of Periodic Safety Update Reports (PSURs) and other regulatory safety documents.
• Monitor and interpret global regulatory guidelines and requirements related to pharmacovigilance and signal detection.
• Maintain accurate and up-to-date records of signal detection activities and related documentation.
• Participate in departmental and cross-functional meetings to discuss safety issues.
• Contribute to the continuous improvement of pharmacovigilance processes and systems.
• Ensure compliance with all applicable company policies and regulatory requirements.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
• A Master's degree or relevant professional certification is a plus.
• Minimum of 3 years of experience in pharmacovigilance, with specific experience in signal detection and evaluation.
• Thorough understanding of pharmacovigilance principles, regulatory requirements (e.g., FDA, EMA), and safety database systems.
• Strong analytical and critical thinking skills, with the ability to interpret complex data.
• Excellent written and verbal communication skills, with the ability to present findings clearly.
• Proven ability to work independently and manage multiple tasks effectively in a remote setting.
• Proficiency in using safety databases and adverse event reporting tools.
• Familiarity with statistical analysis of safety data is advantageous.
• Proactive and detail-oriented approach to work.
• Strong teamwork and collaboration skills.

Benefits

This remote role offers a competitive salary and comprehensive benefits, including private health insurance, a pension fund, and performance-based bonuses. Our client champions work-life balance and offers flexible working hours and generous annual leave. Continuous professional development is supported through online courses, webinars, and virtual conferences. Join a globally recognized pharmaceutical company dedicated to patient safety, with the flexibility to work from your preferred location in South Africa.