Remote Pharmacovigilance Specialist - Signal Detection

Placements24; Paarl; Hybrid; ZAR 700,000 - 1,100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Professional development opportunities

Fully remote work

Job summary

Placements24 is partnering with a globally recognized pharmaceutical company to recruit a Remote Pharmacovigilance Specialist focused on signal detection. You will monitor safety data from spontaneous reports, literature, and trials, and contribute to risk management activities from anywhere in the world.

The role emphasizes proactive signal assessment, data mining, and statistical analysis to inform benefit-risk profiles.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance, with a strong emphasis on signal detection and case processing.
• In-depth knowledge of pharmacovigilance principles, adverse event reporting, and global regulatory requirements (e.g., FDA, EMA).
• Proven experience with signal detection methodologies and statistical analysis of safety data.
• Proficiency in using pharmacovigilance databases and safety reporting software.

Responsibilities

• Proactively identify, assess, and investigate potential safety signals from all available data sources.
• Utilize data mining techniques and statistical tools to analyze large datasets for emerging safety trends.
• Conduct comprehensive benefit-risk assessments for assigned products.
• Prepare detailed signal evaluation reports, including recommendations for further investigation or action.
• Collaborate with internal teams (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) and external stakeholders to manage safety issues.
• Contribute to the preparation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Ensure compliance with global pharmacovigilance regulations and company policies.
• Monitor scientific literature and regulatory intelligence for relevant safety information.
• Participate in cross-functional safety meetings and contribute expert safety insights.
• Maintain accurate and up-to-date records in the safety database.

Skills

Pharmacovigilance

Signal detection

Data analysis

Statistical analysis

Regulatory knowledge

Communication

Education

Bachelor's/Master's in Pharmacy/Life Sciences

Tools

Safety reporting software

Job description

About the Role

Our client, a globally recognized pharmaceutical company committed to patient safety, is actively seeking a Remote Pharmacovigilance Specialist with a strong focus on signal detection. This is a fully remote position, allowing you to contribute significantly to drug safety monitoring from any location. You will be responsible for proactively identifying potential safety signals from various data sources, including spontaneous reports, literature, and clinical trial data. This role involves robust data mining, statistical analysis, and in-depth evaluation of adverse event data to assess the benefit-risk profile of our pharmaceutical products. The ideal candidate possesses a deep understanding of pharmacovigilance principles, signal detection methodologies, and regulatory reporting requirements. If you are a meticulous and analytical professional passionate about ensuring drug safety worldwide, this remote opportunity is perfect for you. This role is inherently remote and requires no physical presence at a company facility.

Key Responsibilities

• Proactively identify, assess, and investigate potential safety signals from all available data sources.
• Utilize data mining techniques and statistical tools to analyze large datasets for emerging safety trends.
• Conduct comprehensive benefit-risk assessments for assigned products.
• Prepare detailed signal evaluation reports, including recommendations for further investigation or action.
• Collaborate with internal teams (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) and external stakeholders to manage safety issues.
• Contribute to the preparation and submission of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Ensure compliance with global pharmacovigilance regulations and company policies.
• Monitor scientific literature and regulatory intelligence for relevant safety information.
• Participate in cross-functional safety meetings and contribute expert safety insights.
• Maintain accurate and up-to-date records in the safety database.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance, with a strong emphasis on signal detection and case processing.
• In-depth knowledge of pharmacovigilance principles, adverse event reporting, and global regulatory requirements (e.g., FDA, EMA).
• Proven experience with signal detection methodologies and statistical analysis of safety data.
• Proficiency in using pharmacovigilance databases and safety reporting software.
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to clearly articulate complex safety information.
• Ability to work independently and manage multiple priorities effectively in a remote setting.
• Meticulous attention to detail and commitment to data accuracy.
• Familiarity with medical terminology and coding conventions (e.g., MedDRA, WHO-ART).

Benefits

Our client offers a competitive salary and a comprehensive benefits package for this remote position, including health, dental, and vision insurance, a retirement savings plan, and generous paid time off. We are committed to fostering a culture of continuous learning and provide ample opportunities for professional development, including training on the latest pharmacovigilance tools and regulations, and support for relevant certifications. The flexibility of a fully remote role allows for an exceptional work-life balance. Our client values collaboration and innovation, providing a platform for you to make a significant impact on global patient safety. Join a dedicated team working at the forefront of drug safety vigilance from the convenience of your home.