Remote Senior Pharmacovigilance Scientist

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Job summary

Placements24 is seeking a highly skilled Remote Senior Pharmacovigilance Scientist in South Africa. You will oversee safety surveillance for assigned products, perform signal detection, and prepare regulatory safety documents such as PSURs and DSURs.

The role requires 5+ years in pharmacovigilance, deep regulatory knowledge, and the ability to work remotely. You will collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to ensure patient safety and compliant reporting

Qualifications

• 5+ years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations (GVP, FDA, SAHPRA).
• Experience in signal detection, risk assessment and safety reports.
• Excellent written and verbal communication, with ability to present complex data clearly.
• Ability to work independently in a remote setting.

Responsibilities

• Perform safety surveillance for assigned products, including case processing oversight and data analysis.
• Conduct signal detection and evaluation, identify safety issues and assess significance.
• Draft and review PSURs, DSURs, and other regulatory safety documents.
• Contribute to RMPs and REMS development and maintenance.
• Liaise with regulators and ensure timely safety report submissions.
• Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs.
• Review investigator brochures and protocols from a safety perspective in trials.
• Develop and implement pharmacovigilance policies and procedures.
• Interpret safety data from spontaneous reports, literature, and studies.
• Stay updated on global PV regulations and best practices.

Skills

Pharmacovigilance

Remote work experience

Regulatory reporting

Data analysis

Communication skills

Education

PharmD, PhD, MSc, MD

Job description

About the Role

Our client, a global leader in pharmaceutical research and development, is seeking a highly skilled and experienced Remote Senior Pharmacovigilance Scientist. This fully remote position allows you to contribute to patient safety from anywhere within South Africa. The Senior Pharmacovigilance Scientist will be responsible for the safety surveillance of assigned products, including signal detection, risk assessment, and regulatory reporting. You will work closely with cross-functional teams to ensure the safe and effective use of our medicines. This role requires a deep understanding of pharmacovigilance principles and regulatory requirements.

Key Responsibilities

• Perform safety surveillance activities for assigned pharmaceutical products, including case processing oversight and data analysis.
• Conduct signal detection and evaluation activities, identifying potential safety issues and assessing their significance.
• Author and review periodic safety update reports (PSURs), development safety update reports (DSURs), and other regulatory safety documents.
• Contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Liaise with regulatory authorities on pharmacovigilance matters and ensure timely submission of safety reports.
• Collaborate with internal stakeholders (e.g., Clinical Operations, Regulatory Affairs, Medical Affairs) to manage product safety.
• Participate in safety monitoring of clinical trials, including reviewing investigator brochures and study protocols from a safety perspective.
• Contribute to the development and implementation of pharmacovigilance policies and procedures.
• Evaluate and interpret safety data from various sources, including spontaneous reports, literature, and clinical studies.
• Stay current with global pharmacovigilance regulations, guidelines, and industry best practices.

Requirements

• Advanced scientific degree (PharmD, PhD, MSc, MD) in a relevant healthcare or life science field.
• A minimum of 5 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical industry.
• Strong understanding of global pharmacovigilance regulations (e.g., GVP, FDA regulations, SAHPRA requirements).
• Proven experience in signal detection, risk assessment, and the preparation of safety reports.
• Excellent analytical, critical thinking, and problem-solving skills.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly and concisely.
• Ability to work independently and manage multiple priorities in a remote setting.
• Proficiency in pharmacovigilance databases and safety reporting systems.
• Experience working with cross-functional teams and external stakeholders.
• Must be legally authorized to work in South Africa and comfortable working remotely.

Benefits

Our client offers a highly competitive salary, a comprehensive benefits package including health insurance and retirement contributions, and significant opportunities for professional growth. This role provides the ultimate flexibility of working remotely from anywhere in South Africa. You will be part of a dedicated team committed to ensuring the safety of patients worldwide, contributing to vital drug safety initiatives. Join a leading organization that values scientific expertise and supports its remote workforce.