Senior Pharmacovigilance Scientist

Placements24; Durban; Hybrid; ZAR 600,000 - 900,000; Full time

Job summary

Placements24 is seeking a Senior Pharmacovigilance Scientist to join a dynamic pharmaceutical team. This fully remote role can be performed from anywhere, including Durban, South Africa, while contributing to global safety monitoring and risk management.

You will lead literature reviews, AE data collection and reporting, PBRER preparation, and signal detection, collaborating with Regulatory, Medical Affairs, and Clinical Development to ensure robust pharmacovigilance and patient safety worldwide.

Qualifications

• Advanced degree in life sciences or related field.
• Minimum 5 years experience in pharmacovigilance or drug safety.
• Strong knowledge of global PV regulations and reporting requirements.
• Experience with adverse event processing and signal detection.
• Ability to work independently in a remote setting.
• Excellent written and verbal communication skills.

Responsibilities

• Perform literature reviews for safety signals and emerging trends.
• Collect, assess and report adverse event data per global regulatory requirements.
• Prepare and review PBRERs and other safety documents.
• Participate in signal detection and risk assessment activities.
• Collaborate with Regulatory Affairs, Medical Affairs, and Clinical Development.
• Contribute to PV strategies and processes.
• Provide safety training and support to stakeholders.
• Ensure compliance with ICH E2 guidelines and health authority responses.

Skills

Literature reviews

Adverse event data interpretation

Signal detection

Remote work management

Regulatory & compliance knowledge

Scientific communication

Education

MS/PhD/PharmD/MD in life sciences

Tools

PV databases

Safety reporting systems

Job description

About the Role

Our client, a dynamic player in the pharmaceutical landscape, is actively seeking a Senior Pharmacovigilance Scientist to join their dedicated team. This role is based in Durban, KwaZulu-Natal, ZA and is structured as a fully remote position, allowing you to contribute your expertise from anywhere. You will be integral in ensuring the safety of our pharmaceutical products by monitoring, collecting, and assessing adverse event data. This position demands a strong understanding of regulatory requirements, exceptional analytical skills, and a proactive approach to safety surveillance. As a Senior Scientist, you will play a crucial role in risk management, signal detection, and the preparation of safety reports. We are committed to fostering a collaborative and supportive remote work environment, where scientific rigor and patient safety are paramount. This is an excellent opportunity to advance your career in pharmacovigilance within a company that values innovation and employee well-being. Your contributions will directly impact the safety profile of our marketed products and pipeline candidates, ensuring compliance and patient protection globally.

Key Responsibilities

• Conduct comprehensive literature reviews for safety signals and emerging trends related to pharmaceutical products.
• Collect, assess, and report adverse event data in accordance with global regulatory requirements and company SOPs.
• Prepare and review Periodic Benefit-Risk Evaluation Reports (PBRERs) and other safety regulatory documents.
• Participate in signal detection and risk assessment activities, providing expert analysis and recommendations.
• Collaborate with internal teams (e.g., Regulatory Affairs, Medical Affairs, Clinical Development) and external partners to manage safety information.
• Contribute to the development and implementation of pharmacovigilance strategies and processes.
• Provide safety-related training and support to internal and external stakeholders.
• Ensure compliance with all applicable pharmacovigilance regulations and guidelines (e.g., ICH E2 series).
• Assist in the preparation of responses to health authority queries regarding product safety.

Requirements

• Advanced degree (M.S., Ph.D., Pharm.D., M.D.) in a life science, medical, or related field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Thorough understanding of global pharmacovigilance regulations, guidelines, and reporting requirements.
• Proven experience in adverse event case processing, signal detection, and risk management.
• Demonstrated ability to interpret complex scientific and medical data.
• Excellent written and verbal communication skills, with the ability to prepare clear and concise reports.
• Strong analytical and problem-solving skills.
• Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote setting.
• Experience with pharmacovigilance databases and safety reporting systems is essential.
• Proficiency in data analysis and interpretation related to drug safety.

Benefits

• Our client offers a competitive salary commensurate with experience, along with performance-based incentives.
• Employees enjoy comprehensive health, dental, and vision insurance coverage.
• A retirement savings plan with employer contributions is provided.
• This role is fully remote, offering the flexibility to work from your preferred location in Durban, KwaZulu-Natal, ZA , or elsewhere.
• We support continuous learning and professional development through access to training resources and industry conferences.
• Generous paid time off, including vacation, sick leave, and public holidays, is standard.
• Opportunities for career advancement within a growing global organization are abundant.
• We are committed to fostering a positive and inclusive work environment that prioritizes employee well-being and recognizes individual contributions.