Senior Pharmacovigilance Specialist - Drug Safety

Placements24; Riverton (UT); Hybrid; USD 48,000 - 73,000; Full time

Benefits offered by this job

Hybrid working model

Private medical aid

Retirement fund

Performance-based bonuses

Professional development

Ongoing training

Support for relevant certifications

Diversity and inclusion

Job summary

Placements24 seeks a Senior Pharmacovigilance Specialist to join a global pharmaceutical safety team in Upington. You will lead adverse event evaluation, ensure regulatory reporting, and drive signal detection across therapy areas.

The role requires strong knowledge of PV regulations, post‑marketing surveillance, and data‑driven decision making. Hybrid work options are available to balance site responsibilities with remote tasks.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Medicine or related life science.
• Master's degree or equivalent advanced qualification preferred.
• Min. 5 years of pharmacovigilance/drug safety experience and global safety regulations knowledge.
• Proficiency in adverse event reporting systems and safety databases.
• Experience with signal detection methodologies and aggregate reporting.
• Strong understanding of clinical trial processes and post‑marketing surveillance.
• Excellent analytical skills and attention to detail.
• Strong written and verbal communication; ability to explain complex safety information.
• Ability to work independently and in a team.
• Familiarity with ICH pharmacovigilance guidelines.

Responsibilities

• Collect, process and assess adverse event reports from multiple sources.
• Perform medical case reviews and determine seriousness and causality.
• Contribute to signal detection activities and identify safety issues.
• Prepare and submit aggregate safety reports to regulators.
• Ensure compliance with global pharmacovigilance regulations and policies.
• Collaborate with Medical Affairs, Regulatory, and Clinical Development on safety.
• Develop and update company safety procedures and training materials.
• Support safety database management and data quality assurance.
• Respond to regulatory authority inquiries regarding product safety.

Skills

Pharmacovigilance

Adverse events

Signal detection

Regulatory reporting

Safety databases

Data analysis

Medical review

Written communication

Team collaboration

Education

Bachelor's degree in Pharmacy, Nursing, Medicine or life science

Master's degree preferred

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking a Senior Pharmacovigilance Specialist to join their dedicated drug safety team. This critical role, based in Upington, Northern Cape , is responsible for ensuring the safety of patients by managing and monitoring adverse event data for pharmaceutical products. The Senior Specialist will play a key role in signal detection, risk assessment, and regulatory reporting, contributing to the ongoing safety profile of the company's portfolio. This position offers a challenging and rewarding opportunity to contribute to patient safety and regulatory compliance within the pharmaceutical industry, working with a diverse range of therapeutic areas.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Perform medical case reviews and determine the seriousness and causality of adverse events.
• Contribute to signal detection activities, identifying potential safety issues proactively.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities.
• Ensure compliance with global pharmacovigilance regulations and company policies.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) on safety-related matters.
• Participate in the development and updating of company safety procedures and training materials.
• Support safety database management and data quality assurance activities.
• Respond to regulatory authority inquiries regarding product safety.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, or a related life science discipline.
• A Master's degree or equivalent advanced qualification is preferred.
• Minimum of 5 years of experience in pharmacovigilance or drug safety, with a strong understanding of global safety regulations.
• Proficiency in adverse event reporting systems and safety databases.
• Experience with signal detection methodologies and aggregate reporting is essential.
• Solid understanding of clinical trial processes and post-marketing surveillance.
• Excellent analytical skills, attention to detail, and ability to make sound scientific judgments.
• Strong written and verbal communication skills, with the ability to articulate complex safety information clearly.
• Ability to work effectively both independently and as part of a collaborative team.
• Familiarity with ICH guidelines related to pharmacovigilance.

Benefits

• competitive salary commensurate with experience
• private medical aid
• a retirement fund
• performance-based bonuses
• professional development
• ongoing training
• support for relevant certifications
• hybrid working model, allowing for flexibility between office-based tasks and remote work, balanced with the advantages of living in the unique landscape of Upington
• supportive and dynamic work environment focused on scientific rigor and patient well-being

We are committed to diversity and inclusion.