Remote Pharmacovigilance Specialist

Placements24; Waukee (IA); Hybride; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Medical aid

Retirement plan

Flexible remote hours

Professional development

Supportive team

Résumé du poste

Placements24 is seeking a proactive Remote Pharmacovigilance Specialist to join their safety team, supporting pharmaceutical operations from anywhere within the United States. You will monitor, evaluate, and report adverse events in line with global PV regulations.

The role requires a Bachelor's in a health field and at least 3 years in pharmacovigilance, with strong MedDRA and data-entry skills, and the ability to liaise with clinicians and regulators.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field.
• Minimum 3 years of pharmacovigilance or drug safety experience.
• Strong knowledge of global PV regulations (ICH E2B, GVP).
• Experience with MedDRA coding and safety databases.
• Excellent written and verbal communication for regulatory reporting.

Responsabilités

• Collect, assess, and document adverse event reports from multiple sources.
• Perform case processing, data entry, and causality/seriousness assessment.
• Prepare and submit PSURs and DSURs as required.
• Conduct literature searches for safety signals.
• Liaise with healthcare professionals and regulators on safety matters.
• Help develop PV procedures and training materials.

Connaissances

Pharmacovigilance

MedDRA coding

ICH E2B/GVP

Data entry

Regulatory liaison

Safety databases

Analytical skills

Attention to detail

Effective communication

Formation

Bachelor's degree in Pharmacy/Life Sciences

Outils

MedDRA coding tools

Safety database systems

Description du poste

About the Role

Our client is seeking a proactive and experienced Remote Pharmacovigilance Specialist to join their dedicated safety team, supporting pharmaceutical operations that may originate from Paarl, Western Cape . This is a fully remote position, allowing you to contribute to patient safety from anywhere within South Africa. You will play a crucial role in monitoring, collecting, and evaluating adverse event reports, ensuring compliance with global pharmacovigilance regulations and contributing to the safe use of pharmaceutical products. Your vigilance is essential in protecting public health.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources, ensuring completeness and accuracy.


• Perform case processing, including data entry into safety databases, coding using MedDRA, and determining seriousness and causality.


• Prepare and submit regulatory safety reports (e.g., Periodic Safety Update Reports - PSURs, Development Safety Update Reports - DSURs) as required.


• Conduct literature searches for potential safety signals and emerging risks.


• Liaise with healthcare professionals, regulatory authorities, and internal stakeholders on safety-related matters.


• Contribute to the development and maintenance of pharmacovigilance procedures and training materials.

Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.


• Minimum of 3 years of experience in pharmacovigilance or drug safety.


• Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., ICH E2B, GVP).


• Experience with safety database systems and MedDRA coding.


• Strong analytical skills and attention to detail in reviewing safety data.


• Excellent written and verbal communication skills for effective reporting and liaison.

Benefits

• Competitive annual salary and performance-related bonuses.


• Comprehensive medical aid and retirement fund.


• Flexible remote working hours and location.


• Paid professional development and training opportunities.


• A supportive team environment focused on maintaining drug safety and public health.