Senior Pharmaceutical Pharmacovigilance Specialist

Placements24; Riverton (UT); On-site; USD 54,000 - 97,000; Full time

Benefits offered by this job

Salary + benefits

Professional development

Exposure to products

Upington work environment

Paid time off

Career growth

Job summary

Placements24 is seeking a Senior Pharmaceutical Pharmacovigilance Specialist to lead adverse event processing and safety reporting for pharmaceutical products. The role emphasizes PSUR/DSUR preparation, regulatory compliance, and cross-functional collaboration with Medical Affairs, Regulatory, and Clinical Development teams.

The successful candidate will have a medical or life sciences degree and at least five years of pharmacovigilance experience, with strong analytical and communication

Qualifications

• Degree in Medicine, Pharmacy, Nursing, Life Sciences or a related field.
• Minimum of 5 years’ pharmacovigilance or drug safety experience.
• Thorough knowledge of global pharmacovigilance regulations and reporting.
• Experience with AE case processing and regulatory reporting systems.
• Familiarity with PSUR/DSUR and signal detection practices.
• Strong analytical, communication and attention to detail.

Responsibilities

• Manage collection, processing, and reporting of adverse events and product complaints.
• Conduct signal detection activities to identify potential safety issues.
• Prepare aggregate safety reports (PSURs, DSURs) for regulators.
• Ensure compliance with pharmacovigilance regulations and guidelines.
• Liaise with Medical Affairs, Regulatory, Clinical Development and external stakeholders.
• Contribute to pharmacovigilance SOPs and risk management plan development.
• Perform literature reviews for safety information and trends.
• Train personnel on pharmacovigilance requirements and procedures.
• Act as subject matter expert on drug safety and pharmacovigilance issues.

Skills

Analytical thinking

Problem-solving

Critical thinking

Written communication

Verbal communication

Attention to detail

Independent work

Education

Medicine / Pharmacy / Nursing / Life Sciences degree

Tools

Pharmacovigilance databases

Job description

About the Role

Our client, a leading pharmaceutical company with operations in Upington, Northern Cape, is actively seeking a dedicated Senior Pharmaceutical Pharmacovigilance Specialist. This critical role ensures the safety and ongoing monitoring of pharmaceutical products once they are on the market. The Specialist will be responsible for managing adverse event reporting, conducting signal detection and assessment, and ensuring compliance with global pharmacovigilance regulations. The ideal candidate will possess a strong understanding of drug safety principles and regulatory requirements within the pharmaceutical industry. Join our client's committed team in Upington and play a vital role in patient safety.

Key Responsibilities

• Manage the collection, processing, and reporting of adverse event (AE) and product complaint data.
• Conduct signal detection activities to identify potential safety issues associated with pharmaceutical products.
• Prepare aggregate safety reports (e.g., PSURs, DSURs) for submission to regulatory authorities.
• Ensure compliance with all applicable pharmacovigilance regulations and guidelines (e.g., GVP modules, CIOMS).
• Liaise with internal departments (Medical Affairs, Regulatory Affairs, Clinical Development) and external stakeholders (healthcare professionals, regulatory agencies) on safety matters.
• Contribute to the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Participate in risk management plan development and implementation.
• Perform literature reviews for safety information and emerging trends.
• Train relevant personnel on pharmacovigilance requirements and procedures.
• Act as a subject matter expert on drug safety and pharmacovigilance issues.

Requirements

• Degree in Medicine, Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A minimum of 5 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of global pharmacovigilance regulations and reporting requirements.
• Experience with adverse event case processing and regulatory reporting systems.
• Familiarity with signal detection methodologies and aggregate safety reporting.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with high attention to detail.
• Ability to work independently and manage workload effectively in a demanding environment.
• Proficiency in pharmacovigilance database systems and common office software.
• Prior experience in the pharmaceutical industry within the Northern Cape or similar context is beneficial.

Benefits

• Competitive salary and a comprehensive benefits package.
• Opportunities for continuous professional development and training in drug safety.
• Exposure to a wide range of pharmaceutical products and safety profiles.
• A stable and supportive work environment in Upington.
• Generous paid time off and company holidays.
• Potential for career growth within a growing organization.