Lead Pharmacovigilance Manager

Placements24; Cape Town; On-site; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Competitive remuneration

Medical aid

Retirement fund

International travel opportunities

Professional development

Generous annual leave

On-site amenities

Job summary

Placements24 in Cape Town seeks an experienced Lead Pharmacovigilance Manager to oversee safety monitoring systems, ensure timely reporting of adverse events, and drive risk management.

You will develop PV procedures, liaise with authorities, manage inspections, and lead a high-performing team, with opportunities for international conferences and ongoing professional development.

Qualifications

• Master's degree or higher in Medicine, Pharmacy, Life Sciences, or related healthcare field.
• Minimum of 8 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
• Extensive knowledge of global PV regulations and guidelines (ICH, CIOMS, FDA, EMA).
• Experience managing adverse event reporting systems and databases.
• Proven ability to conduct signal detection, risk assessment, and risk management planning.
• Strong leadership and team management skills with ability to motivate and develop a team.
• Excellent analytical, problem-solving, and decision-making capabilities.
• Exceptional communication and interpersonal skills with regulatory bodies and internal departments.

Responsibilities

• Lead and manage the day-to-day operations of the pharmacovigilance department.
• Ensure compliance with global regulatory requirements for pharmacovigilance, including ICSR reporting.
• Develop, implement, and maintain pharmacovigilance procedures and policies.
• Oversee the collection, assessment, and reporting of adverse event data.
• Conduct periodic safety reviews and prepare aggregate safety reports (e.g., PSURs, DSURs).
• Manage regulatory inspections and audits related to pharmacovigilance activities.
• Develop and deliver training programs on pharmacovigilance for internal stakeholders.
• Liaise with regulatory authorities, investigators, and other stakeholders on safety-related matters.
• Participate in cross-functional teams to assess product risks and benefits.

Skills

Leadership

Regulatory knowledge

Pharmacovigilance expertise

Data analysis

Education

Master's degree or higher in Medicine, Pharmacy, Life Sciences, or related field

Job description

About the Role

Our client, a prominent player in the global pharmaceutical landscape, is seeking an experienced and strategic Lead Pharmacovigilance Manager to oversee and enhance their safety monitoring systems. This critical position will be based in our modern facilities in Cape Town, Western Cape, ZA. The role demands a deep understanding of drug safety regulations and a proven ability to manage complex pharmacovigilance operations. You will be responsible for ensuring the timely and accurate reporting of adverse events, conducting signal detection and risk assessment, and contributing to the overall safety profile of our client's marketed products. This is an exceptional opportunity for a dedicated professional to lead a vital function within a highly respected pharmaceutical organization, safeguarding public health and maintaining regulatory compliance. The ideal candidate will possess strong leadership qualities and a commitment to excellence in pharmacovigilance.

Key Responsibilities

• Lead and manage the day-to-day operations of the pharmacovigilance department.
• Ensure compliance with global regulatory requirements for pharmacovigilance, including ICSR reporting.
• Develop, implement, and maintain pharmacovigilance procedures and policies.
• Oversee the collection, assessment, and reporting of adverse event data.
• Conduct periodic safety reviews and prepare aggregate safety reports (e.g., PSURs, DSURs).
• Manage regulatory inspections and audits related to pharmacovigilance activities.
• Develop and deliver training programs on pharmacovigilance for internal stakeholders.
• Liaise with regulatory authorities, investigators, and other stakeholders on safety-related matters.
• Participate in cross-functional teams to assess product risks and benefits.

Requirements

• Master's degree or higher in Medicine, Pharmacy, Life Sciences, or a related healthcare field.
• Minimum of 8 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
• Extensive knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, CIOMS, FDA, EMA).
• Demonstrated experience in managing adverse event reporting systems and databases.
• Proven ability to conduct signal detection, risk assessment, and risk management planning.
• Strong leadership and team management skills with the ability to motivate and develop a team.
• Excellent analytical, problem-solving, and decision-making capabilities.
• Exceptional communication and interpersonal skills, with the ability to effectively interact with regulatory bodies and internal departments.
• Experience with medical terminology and case processing is essential.

Benefits

• Highly competitive remuneration package.
• Comprehensive medical aid and retirement fund contributions.
• Opportunities for international travel and professional conferences.
• Subsidized on-site amenities.
• Support for professional development and certifications.
• Generous annual leave allowance.
• A stable and reputable organization with a strong commitment to employee well-being.