Remote Senior Pharmacovigilance Specialist

Placements24; Queenstown; Híbrido; NZD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Remote work

Home office stipend

Professional development

Resumo da oferta

Placements24 is seeking a Senior Pharmacovigilance Specialist for a fully remote role. You will monitor, assess, and report adverse events to ensure patient safety on a global scale, collaborating with international teams via digital platforms.

The role requires at least 5 years in pharmacovigilance, strong regulatory knowledge, AE processing, and data analysis skills. Remote collaboration, meticulous data management, and adherence to safety standards are essential.

Qualificações

• Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry.
• Strong knowledge of global PV regulations (FDA/EMA/CIOMS/ICH).
• Experience with AE case processing and risk assessment.

Responsabilidades

• Manage end-to-end collection, assessment, and reporting of AE and PQC data.
• Submit safety reports to regulators globally per regulations and guidelines.
• Prepare PSURs/PBRERs and other safety documents.

Conhecimentos

Pharmacovigilance

AE case processing

Signal detection

Risk assessment

Regulatory knowledge

Data analysis

Communication skills

Formação académica

Bachelor's in Pharmacy/Life Sciences/Nursing/Medicine

Master's degree advantageous

Ferramentas

PV databases

Safety reporting software

Descrição da oferta de emprego

About the Role

Our client, a global pharmaceutical leader dedicated to patient safety, is seeking a highly experienced Senior Pharmacovigilance Specialist to join their fully remote team. This pivotal role involves monitoring, assessing, and reporting adverse events to ensure the safe use of pharmaceutical products worldwide. As a remote-first position, you will leverage your expertise in pharmacovigilance regulations and data analysis to contribute to a robust safety monitoring system, working collaboratively with international teams through advanced digital platforms. The ideal candidate will possess a strong understanding of global regulatory requirements for pharmacovigilance, excellent analytical skills, and a meticulous approach to data management. This is an exceptional opportunity to make a significant impact on public health from the comfort of your home office, contributing to a company that values integrity and patient well-being. We are committed to providing a supportive and collaborative remote work environment for our safety professionals.

Key Responsibilities

• Manage the end-to-end process of collecting, assessing, and reporting adverse event (AE) and product quality complaint (PQC) data for assigned products.
• Ensure timely and accurate submission of safety reports to regulatory authorities globally, adhering to all applicable regulations and guidelines.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Prepare and contribute to the development of periodic safety update reports (PSURs/PBRERs) and other regulatory safety documents.
• Participate in safety management team meetings and contribute to risk management planning activities.
• Collaborate with clinical operations, regulatory affairs, medical affairs, and external partners to ensure comprehensive safety monitoring.
• Develop and maintain pharmacovigilance procedures and work instructions, ensuring compliance and best practices.
• Train and mentor junior pharmacovigilance staff on regulatory requirements and company processes.
• Perform quality control checks on safety data and reports to ensure accuracy and completeness.
• Stay updated on global pharmacovigilance regulations, guidelines, and industry trends.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, Medicine, or a related healthcare field.
• A Master's degree or equivalent is advantageous.
• A minimum of 5 years of experience in pharmacovigilance, drug safety, or a related field within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and reporting requirements (e.g., FDA, EMA, CIOMS, ICH).
• Proven experience in AE case processing, signal detection, and risk assessment.
• Proficiency with pharmacovigilance databases and safety reporting software.
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to convey complex safety information clearly.
• Ability to work independently, manage multiple tasks efficiently, and meet strict deadlines in a remote environment.
• Experience with remote collaboration tools and maintaining productivity in a virtual setting.
• High level of ethical integrity and commitment to patient safety.

Benefits

• Our client offers a highly competitive salary, comprehensive health insurance coverage, and a generous retirement savings plan.
• This fully remote role provides exceptional work-life balance and the flexibility to work from anywhere within the designated region.
• Professional development is strongly encouraged, with opportunities for advanced training, certifications, and participation in industry conferences.
• We foster a collaborative and supportive virtual team environment.
• Additional benefits include a home office stipend and access to continuous learning platforms.
• Join a company committed to global health and safety.