Senior Pharmacovigilance Scientist (Remote)

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Medical insurance

Professional development

Remote work

Job summary

Placements24 is seeking a Senior Pharmacovigilance Scientist for a fully remote role with a focus on Sandton regulatory operations. You will monitor, evaluate, and report adverse events, contributing to PSURs/PBRERs and RMPs while collaborating across regulatory, clinical, and medical affairs teams.

The ideal candidate holds an advanced degree (M.D., Pharm.D., Ph.D., M.Sc.) with 5+ years in pharmacovigilance, strong regulatory knowledge, and proficiency with safety databases and reporting

Qualifications

• Advanced degree in a relevant scientific or healthcare discipline.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Comprehensive knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and critical thinking skills for evaluating safety data.
• Excellent written and verbal communication skills, essential for remote collaboration.

Responsibilities

• Monitor and evaluate adverse event data from clinical trials, post-marketing surveillance, and literature.
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Contribute to preparation of PSURs/PBRERs and risk management plans (RMPs).
• Participate in safety signal detection and risk assessment activities.
• Collaborate with clinical teams to ensure robust safety data collection and management.
• Stay current with global pharmacovigilance regulations and guidelines.

Skills

Pharmacovigilance

Data analysis

Regulatory knowledge

Medical writing

Remote collaboration

Education

M.D./Pharm.D./Ph.D./M.Sc.

Tools

Safety databases

AE reporting systems

Job description

About the Role

Our client is seeking a highly experienced and motivated Senior Pharmacovigilance Scientist to join their safety surveillance team on a fully remote basis, supporting operations relevant to Sandton . This pivotal role focuses on ensuring the safety of patients by monitoring, evaluating, and reporting adverse events associated with pharmaceutical products. You will work closely with regulatory affairs, clinical operations, and medical affairs teams to manage drug safety data and contribute to risk management strategies. This fully remote position demands a strong understanding of safety reporting requirements and the ability to analyze complex safety data effectively.

Key Responsibilities

• Monitor and evaluate adverse event data from various sources, including clinical trials, post-marketing surveillance, and literature.
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Participate in safety signal detection and risk assessment activities.
• Collaborate with clinical teams to ensure robust safety data collection and management.
• Stay current with global pharmacovigilance regulations and guidelines.

Requirements

• Advanced degree (M.D., Pharm.D., Ph.D., M.Sc.) in a relevant scientific or healthcare discipline.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Comprehensive knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and critical thinking skills for evaluating safety data.
• Excellent written and verbal communication skills, essential for remote collaboration.

Benefits

• Highly competitive annual salary and a generous performance-based incentive plan.
• Comprehensive medical, dental, and vision insurance benefits.
• Opportunities for professional development and continuous learning in pharmacovigilance.
• A flexible and autonomous fully remote work environment.
• The opportunity to play a key role in ensuring patient safety and drug efficacy.