Senior Pharmacovigilance Manager

Placements24; Vereeniging; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Competitive salary

Bonus structure

Health, dental, vision insurance

Generous pension contributions

Annual leave and PTO

International travel opportunities

Leadership development

Job summary

Placements24 is seeking a Senior Pharmacovigilance Manager for our client in Vereeniging, Gauteng. The role leads a PV team responsible for collecting, assessing, and reporting adverse events for marketed products and clinical trials, ensuring compliance with global regulations.

The successful candidate will oversee safety database management, author safety reports (DSURs/PBRERs), develop PV strategies, train staff, and collaborate with clinical, regulatory and external partners to safeguard

Qualifications

• 7–10 years in pharmacovigilance with leadership exposure.
• Experience in global PV regulations and regulatory reporting.

Responsibilities

• Lead day-to-day PV operations ensuring global safety compliance.
• Oversee AE data collection, assessment and reporting for marketed products and trials.
• Develop PV strategies, SOPs, and safety reporting to authorities (DSURs, PBRERs).
• Manage safety databases and ensure data integrity.
• Mentor staff and collaborate with clinical, regulatory, and external partners.

Skills

Leadership

Communication

Analytical thinking

Regulatory knowledge

Team management

Education

MD/MBBS or MSc in Life Sciences

Tools

Argus

ArisG

Job description

About the Role

Our client, a leading pharmaceutical company with a strong commitment to patient safety, is seeking an experienced Senior Pharmacovigilance Manager to oversee their operations in Vereeniging, Gauteng. This vital role is responsible for ensuring the robust safety monitoring of our client's marketed products and investigational drugs. You will lead a dedicated team responsible for collecting, assessing, and reporting adverse event data in compliance with global regulatory requirements. The ideal candidate will possess extensive knowledge of pharmacovigilance principles, regulatory guidelines (e.g., ICH E2B, E2C), and safety database management. This is a challenging and rewarding opportunity to contribute significantly to patient safety and regulatory compliance within the pharmaceutical industry. You will collaborate closely with clinical operations, medical affairs, regulatory affairs, and external partners to maintain the highest standards of drug safety surveillance. The successful candidate will demonstrate strong leadership qualities, excellent analytical and communication skills, and a meticulous approach to data management and reporting. We are looking for a proactive and experienced professional who can effectively manage complex safety profiles and ensure timely and accurate reporting of safety information. Your expertise will be instrumental in safeguarding public health.

Key Responsibilities

• Lead and manage the day-to-day operations of the pharmacovigilance department, ensuring compliance with global safety regulations.
• Oversee the accurate and timely collection, assessment, and reporting of adverse event data for both marketed products and clinical trials.
• Develop and implement pharmacovigilance strategies, policies, and standard operating procedures (SOPs).
• Ensure compliance with global regulatory requirements for safety reporting (e.g., DSURs, PBRERs, IC SRs).
• Manage and maintain safety databases, ensuring data integrity and quality.
• Conduct signal detection and risk assessment activities to identify potential safety issues.
• Prepare safety reports for regulatory authorities, ethics committees, and internal stakeholders.
• Collaborate with clinical teams to ensure appropriate safety monitoring plans are in place for clinical trials.
• Train and mentor pharmacovigilance staff, fostering a culture of safety and compliance.
• Liaise with external partners, including CROs and licensing partners, on pharmacovigilance matters.

Requirements

• Medical degree (MD, MBBS) or equivalent, or a Master's degree in Pharmacy, Nursing, or a related life science discipline.
• Minimum of 7-10 years of progressive experience in pharmacovigilance, with at least 3 years in a management or leadership role.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Proven experience in managing adverse event case processing and regulatory reporting.
• Experience with safety database systems (e.g., Argus, ArisG) and proficiency in signal detection methodologies.
• Excellent leadership, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities with a meticulous attention to detail.
• Ability to work effectively under pressure and manage multiple priorities.
• Experience in authoring PBRERs/DSURs is essential.
• Fluency in English; additional language skills are an asset.

Benefits

• Highly competitive salary package.
• Performance-related bonus structure.
• Comprehensive health, dental, and vision insurance.
• Generous pension contributions.
• Substantial annual leave and paid time off.
• Opportunities for international travel and professional conferences.
• Leadership development programs.
• Work within a company that prioritizes patient safety and ethical practices.