Remote Pharmacovigilance Specialist

Placements24; Pretoria; Hybrid; ZAR 650,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development

Job summary

Placements24 is seeking a proactive Remote Pharmacovigilance Specialist to strengthen the safety monitoring team for a globally connected pharmaceutical client. The role is entirely remote within South Africa, enabling you to contribute to drug safety from your home location while collaborating with cross-functional teams.

You will collect and assess adverse event data, ensure regulatory reporting, and support PV activities from Pretoria or other SA locations.

Qualifications

• Bachelor’s degree in a health field; 3+ years PV experience.
• Knowledge of ICH E2 series, FDA, EMA PV requirements.
• Experience with safety databases and AE reporting systems.

Responsibilities

• Collect, process, and evaluate AE reports from multiple sources.
• Ensure timely reporting to regulators and stakeholders per global regs.
• Conduct literature reviews for signal detection.
• Prepare PBRERs or DSURs.
• Participate in safety strategy meetings and risk plans.
• Collaborate with Medical, Regulatory, Clinical Ops and partners on PV matters.
• Develop and maintain PV SOPs.
• Train and mentor junior PV staff.
• Identify and assess potential safety signals.

Skills

Analytical thinking

Regulatory knowledge

Communication skills

Independent work

Education

Bachelor’s degree in Pharmacy, Medicine, Nursing, Life Sciences, or related healthcare field

Tools

Argus

ArisG

AE reporting systems

Job description

About the Role

Our client, a distinguished pharmaceutical company with a global reach, is seeking a proactive and experienced Remote Pharmacovigilance Specialist to bolster their safety monitoring team. This is a completely remote role, allowing you to contribute significantly to drug safety from any approved location within South Africa. You will play a critical role in ensuring the safety of our client's medicinal products by monitoring, collecting, and assessing adverse event data. This position requires a sharp analytical mind, a thorough understanding of regulatory safety requirements, and an unwavering commitment to patient well-being. As we operate on a remote-first principle, we provide robust digital infrastructure and support to ensure seamless collaboration and productivity. This is an outstanding opportunity to join a company dedicated to maintaining the highest standards of pharmaceutical safety and to impact public health positively. You will be integral to safeguarding the integrity of our pharmaceutical portfolio.

Key Responsibilities

• Collect, process, and evaluate adverse event (AE) reports from various sources, including healthcare professionals, patients, and literature.
• Ensure accurate and timely reporting of safety information to regulatory authorities and internal stakeholders in compliance with global regulations.
• Conduct literature reviews for signal detection and contribute to safety database maintenance.
• Prepare aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) or Development Safety Update Reports (DSURs).
• Participate in safety strategy meetings and contribute to risk management plans.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Operations) and external partners on safety-related matters.
• Contribute to the development and maintenance of Standard Operating Procedures (SOPs) related to pharmacovigilance activities.
• Train and mentor junior team members or new hires on PV processes.
• Actively participate in the identification and assessment of potential safety signals.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related healthcare field.
• A minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry or a Contract Research Organization (CRO).
• Thorough knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH E2 series, FDA, EMA requirements).
• Experience with safety databases (e.g., Argus, ArisG) and adverse event reporting systems.
• Strong analytical skills with the ability to interpret complex safety data and identify potential safety signals.
• Excellent written and verbal communication skills, with the ability to prepare clear and concise reports.
• High level of accuracy and attention to detail.
• Ability to work independently, manage time effectively, and meet deadlines in a remote work environment.
• Proficiency in MS Office Suite and familiarity with medical terminology.

Benefits

This fully remote role offers a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and opportunities for professional development. Our client believes in fostering a flexible and supportive remote work culture, providing the necessary tools and resources for success. You will have the flexibility to work from your preferred location within South Africa, contributing to critical drug safety initiatives. This position, conceptually aligned with **Pretoria, Gauteng**, offers a unique chance to advance your career in pharmacovigilance while maintaining a healthy work-life balance. We are committed to employee growth and provide avenues for continuous learning and skill enhancement.