Lead Pharmacovigilance Specialist - Hybrid

Placements24; Cape Town; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Placements24 is seeking a Lead Pharmacovigilance Specialist for a prominent pharmaceutical company in Cape Town, offering a hybrid work arrangement that combines remote flexibility with in-office collaboration.

You will oversee end-to-end adverse event processing, ensure SAHPRA and global regulatory compliance, develop safety analytics, PSURs, and mentor the PV team.

Qualifications

• Master's degree or Pharm.D. in Pharmacy, Medicine or life sciences.
• 6+ years of pharmacovigilance experience in pharma/biotech.
• Strong knowledge of ICH-GCP and ICH-GVP compliance.
• Experience with pharmacovigilance databases (e.g., Argus, ArisG) and safety reporting.

Responsibilities

• Manage end-to-end adverse event case processing and reporting to regulators.
• Ensure compliance with SAHPRA and global pharmacovigilance guidelines.
• Conduct safety data analysis and signal detection activities.
• Prepare PSURs/PBRERs and other safety documentation.
• Develop PV policies, procedures and training programs.
• Collaborate with regulatory, clinical, and medical affairs teams on safety issues.
• Mentor PV team members to foster excellence and continuous improvement.

Skills

Leadership

Analytical thinking

Communication

Problem solving

Education

Master's degree or Pharm.D.

Tools

Argus

ArisG

Job description

About the Role

Our client is a prominent pharmaceutical company seeking a highly skilled and experienced Lead Pharmacovigilance Specialist to join their expanding team in **Cape Town, Western Cape, ZA**. This hybrid role offers a blend of remote flexibility and in-office collaboration, providing a dynamic work environment. The Lead Pharmacovigilance Specialist will be responsible for ensuring the accurate and timely reporting of adverse events, contributing to drug safety surveillance, and maintaining regulatory compliance. You will play a crucial role in safeguarding public health by monitoring the safety profiles of our client's pharmaceutical products throughout their lifecycle. This position requires a deep understanding of pharmacovigilance principles and a commitment to excellence in drug safety.

Key Responsibilities

• Manage and oversee the end-to-end process of adverse event case processing, including data collection, assessment, and reporting to regulatory authorities.
• Ensure compliance with global pharmacovigilance regulations and guidelines, including those set by the South African Health Products Regulatory Authority (SAHPRA) and other relevant bodies.
• Conduct safety data analysis and signal detection activities, identifying potential safety concerns and trends.
• Contribute to the preparation and submission of periodic safety update reports (PSURs/PBRERs) and other safety documents.
• Develop and implement pharmacovigilance policies, procedures, and training programs for relevant stakeholders.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to address safety-related issues.
• Mentor and provide guidance to junior pharmacovigilance team members, fostering a culture of continuous improvement and expertise.

Requirements

• Master's degree or Pharm.D. in Pharmacy, Medicine, or a related life science field.
• A minimum of 6 years of relevant experience in pharmacovigilance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of ICH-GCP, ICH-GVP, and relevant global regulatory requirements for drug safety.
• Proven experience with pharmacovigilance databases (e.g., Argus, ArisG) and safety reporting systems.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong leadership and team management capabilities, with the ability to motivate and guide a team.
• Exceptional written and verbal communication skills, with the ability to present complex information clearly and concisely.
• Ability to work effectively in a hybrid model, balancing remote work with necessary in-office collaboration in **Cape Town, Western Cape, ZA**.

Benefits

Our client offers a competitive salary package, commensurate with experience and qualifications. Employees are eligible for comprehensive health insurance, including medical and dental coverage, as well as a robust retirement savings plan. We provide ample paid time off, including annual leave and sick leave. Opportunities for professional growth and development are actively encouraged through internal and external training programs. This hybrid role provides the flexibility to manage your work-life balance while contributing to a vital area of healthcare from **Cape Town, Western Cape, ZA**. Join a dedicated team committed to ensuring the safety and efficacy of medicines.