Pharmacovigilance Specialist - Drug Safety

Placements24; Queenstown (MD); Hybrid; USD 31,000 - 46,000; Full time

Benefits offered by this job

Medical aid

Retirement savings

Performance-related bonuses

Hybrid work model

Job summary

Placements24 is seeking a Pharmacovigilance Specialist to join a growing Drug Safety team in a hybrid role based in Queenstown, Eastern Cape. The role focuses on collecting, assessing, and reporting adverse events post-marketing, ensuring safety data quality and regulatory compliance.

You will write narratives, code cases with MedDRA, and contribute to aggregate safety reports while collaborating with clinical and regulatory teams to uphold patient safety and product quality.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• 3–5 years of pharmacovigilance or drug safety experience.
• Knowledge of global PV regulations (ICH E2A/E2B/E2C) and reporting.
• Experience with safety databases (Argus, ARISg) and MedDRA coding.

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely reporting of AEs and SAEs to regulatory authorities and stakeholders.
• Maintain the pharmacovigilance database for data quality and integrity.
• Perform case narratives and MedDRA coding.
• Prepare aggregate safety reports (PBRERs, Signal Detection).
• Collaborate with clinical, regulatory, and medical teams for safety assessments.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Participate in audits and regulatory inspections related to drug safety.
• Contribute to developing PV procedures and guidelines.
• Identify potential safety signals and assist in evaluation and management.

Skills

Analytical thinking

Attention to detail

Communication skills

Team collaboration

Data entry

MedDRA coding

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Argus

ARISg

Job description

About the Role

Our client, a rapidly growing pharmaceutical company, is seeking a diligent and experienced Pharmacovigilance Specialist to join their Drug Safety department. This hybrid role, based in the Eastern Cape, will be instrumental in ensuring the safety of our client's pharmaceutical products post-marketing. You will be responsible for the accurate and timely collection, assessment, and reporting of adverse event data to regulatory authorities. This is a critical position that requires a strong understanding of pharmacovigilance principles, regulatory requirements, and a commitment to patient safety. We are looking for an individual who can contribute to maintaining the highest safety standards for our products and uphold our client's reputation for safety and quality in Queenstown, Eastern Cape .

Key Responsibilities

• Collect, process, and evaluate adverse event (AE) reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure the accurate and timely reporting of AEs and Serious Adverse Events (SAEs) to regulatory authorities and internal stakeholders according to global timelines.
• Maintain the pharmacovigilance database, ensuring data quality and integrity.
• Perform case narrative writing and medical coding (MedDRA).
• Contribute to the preparation of aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Signal Detection reports.
• Collaborate with clinical teams, regulatory affairs, and medical affairs to ensure comprehensive safety assessments.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Participate in internal audits and support external regulatory inspections related to drug safety.
• Contribute to the development and revision of pharmacovigilance procedures and guidelines.
• Identify potential safety signals and participate in their evaluation and management.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., ICH E2A, E2B, E2C) and reporting requirements.
• Experience with safety databases (e.g., Argus, ARISg) and MedDRA coding.
• Strong analytical and critical thinking skills with excellent attention to detail.
• Proficiency in data entry, case processing, and medical terminology.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a hybrid work environment.
• Strong organizational skills and ability to manage multiple tasks and deadlines.
• Familiarity with clinical trial safety is a plus.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including medical aid, retirement savings, and performance-related bonuses.
• This hybrid role provides a flexible working arrangement, balancing office-based responsibilities with remote work capabilities.
• You will have opportunities for professional growth and development within a dedicated drug safety team.
• Our client is committed to fostering a culture of safety, quality, and continuous improvement in Queenstown, Eastern Cape , and values the contributions of its employees.
• This is a chance to play a vital role in safeguarding public health.