Senior Pharmacovigilance Specialist - Remote

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work

Flexible schedule

Health benefits

Job summary

Placements24 is seeking a Senior Pharmacovigilance Specialist for a fully remote position based in South Africa. You will manage safety data, perform signal detection, and prepare regulatory reports in alignment with GVP and ICH guidelines.

The role emphasizes independence, meticulous data integrity, and collaboration with cross-functional teams. The ideal candidate has 4+ years in PV, experience with Argus/ARISg, and strong communication skills.

Qualifications

• 4+ years of pharmacovigilance experience with AE processing and regulatory reporting.
• Strong knowledge of GVP and ICH guidelines (E2B, E2C).
• Experience with safety databases Argus and ARISg.
• Excellent written and verbal communication; medical terminology.
• Ability to work independently in a remote setting.

Responsibilities

• Manage and process adverse event reports and data entry.
• Perform case assessments including causality and seriousness.
• Conduct signal detection to identify new safety concerns.
• Prepare and submit PBRERs and DSURs to regulators.
• Maintain IBs, RMPs, PSURs and other safety documents.
• Collaborate with cross-functional teams on safety matters.
• Train and mentor junior PV staff.

Skills

Pharmacovigilance

Adverse event processing

Signal detection

Regulatory reporting

Data analysis

Education

Bachelor's degree in Pharmacy

Master's degree in life sciences

Tools

Argus

ARISg

MS Office

Job description

About the Role

Our client, a distinguished global pharmaceutical company committed to ensuring the safety and efficacy of its medicines, is actively seeking a Senior Pharmacovigilance Specialist for a fully remote position. This crucial role involves the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. The Senior PV Specialist will be responsible for managing safety data, conducting signal detection activities, contributing to regulatory reporting, and ensuring compliance with global pharmacovigilance regulations. This position requires a meticulous approach, strong analytical skills, and a comprehensive understanding of safety reporting requirements. As a remote professional, you will play a key part in safeguarding public health by contributing to the ongoing safety monitoring of pharmaceutical products, working independently from your home office. This is an exceptional opportunity to advance your career in pharmacovigilance within a flexible, remote environment, contributing to patient safety on a global scale. The role is based within South Africa.

Key Responsibilities

• Manage and process adverse event reports from various sources, ensuring timely and accurate data entry into safety databases.
• Perform case assessments, including causality evaluation and seriousness determination.
• Conduct signal detection activities to identify potential new safety concerns related to assigned products.
• Prepare and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities.
• Contribute to the development and maintenance of safety documents, such as Investigator's Brochures (IBs), Risk Management Plans (RMPs), and Periodic Safety Update Reports (PSURs).
• Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Liaise with internal departments (e.g., Regulatory Affairs, Clinical Operations, Medical Affairs) and external stakeholders (e.g., healthcare professionals, regulatory agencies) on safety matters.
• Participate in safety monitoring committees and risk management activities.
• Contribute to the development and improvement of pharmacovigilance processes and systems.
• Train and mentor junior pharmacovigilance staff as needed.

Requirements

• Bachelor's or Master's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field. A Master's degree in a relevant area is advantageous.
• Minimum of 4 years of experience in pharmacovigilance, including experience with adverse event processing, signal detection, and regulatory reporting.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., GVP, ICH E2B, E2C).
• Experience with safety databases (e.g., Argus, ARISg) and adverse event reporting systems.
• Strong analytical skills with the ability to interpret complex safety data and identify trends.
• Excellent written and verbal communication skills, with proficiency in medical terminology.
• Ability to work independently, manage multiple tasks, and meet strict deadlines in a remote setting.
• Proficiency in standard office software (e.g., Microsoft Office Suite).
• A detail-oriented approach and a strong commitment to patient safety and data integrity.
• Ability to collaborate effectively with cross-functional teams.

Benefits

• This fully remote position offers a highly competitive salary, comprehensive health and wellness benefits, a retirement savings plan, and potential for performance-based bonuses.
• Our client provides a supportive and flexible work environment, fostering professional growth and development through ongoing training and opportunities to expand your expertise in pharmacovigilance.
• This role allows for excellent work-life balance and the chance to make a significant contribution to patient safety from anywhere within South Africa.