Pharmacovigilance Specialist

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 520,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Hybrid work

Professional development

Job summary

Placements24 seeks a vigilant Pharmacovigilance Specialist for their Nelspruit team. You will monitor post-market drug safety, collect and assess adverse events, and report to authorities to ensure compliance.

The role requires a health-related degree and at least 3 years in pharmacovigilance, with strong regulatory knowledge, data handling, and communication skills. Hybrid work and development opportunities are offered.

Qualifications

• 3+ years in pharmacovigilance or related regulatory role.
• Knowledge of FDA, EMA, SAHPRA regulations and reporting requirements.
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and written/verbal communication skills.

Responsibilities

• Collect, assess, and document adverse event reports from sources.
• Process safety data in the PV database per procedures and regulatory requirements.
• Prepare and submit PSURs and DSURs to health authorities.
• Liaise with internal departments and external stakeholders on safety issues.
• Conduct literature reviews for potential safety signals and risks.
• Support audits and regulatory inspections related to pharmacovigilance.

Skills

Pharmacovigilance

Regulatory knowledge

Safety reporting

Data entry

Communication skills

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Nursing

Bachelor's degree in Life Sciences

Tools

Safety databases

ADE reporting systems

Job description

About the Role

Our client seeks a vigilant and detail-oriented Pharmacovigilance Specialist to join their team in Nelspruit . This role is crucial for monitoring the safety of pharmaceutical products post-market, ensuring that potential adverse events are identified, assessed, and managed effectively to protect public health. You will work with a dedicated safety team to collect, process, and report safety information according to global regulatory standards. This position offers a vital role in ensuring drug safety and compliance within the pharmaceutical industry.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Process safety data in the pharmacovigilance database in accordance with company procedures and regulatory requirements.
• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports - PSURs, Development Safety Update Reports - DSURs) to health authorities.
• Liaise with internal departments and external stakeholders on safety-related matters.
• Conduct literature reviews for potential safety signals and emerging risks.
• Support audits and regulatory inspections related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance , drug safety, or a related regulatory compliance role.
• Knowledge of global pharmacovigilance regulations and reporting requirements (e.g., FDA, EMA, SAHPRA).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical, written, and verbal communication skills.
• Ability to manage multiple tasks, prioritize effectively, and meet deadlines.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive health, dental, and vision benefits.
• Support for continuous professional development in drug safety.
• A collaborative and supportive team environment focused on patient safety.
• Flexible working arrangements, including hybrid work options.
• Paid time off and company holidays.