Senior PV Officer

Job not on LinkedIn

🔥 15 hours ago

🌐 New Zealand, India – Remote

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⏰ Full Time

🟠 Senior

👻 Ghost score 17%

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Logo of ERGOMED

ERGOMED

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Provide support to project team activities on behalf of clients and the company • Process Individual Case Safety Reports (ICSRs) from all sources in compliance with regulations, procedures, client requirements, and timelines • Perform ICSR follow-up, including SAE/SUSAR management, unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review • Perform clinical and partner reconciliation • Manage personal data protection activities • Handle Product Quality Complaints and interact with Quality Assurance • Interact with Medical Information teams • Perform MedDRA and WHO coding • Produce database outputs and reports, including monthly client reporting data • Manage workflow and resources • Mentor and train new and junior employees • Support pharmacovigilance processes for PrimeVigilance and clients • Support or contribute as an ICSR Subject Matter Expert • Support the RA & PV Network Department as needed • Act as Local Contact Person for Pharmacovigilance (LCPPV) for a specified country and Person Responsible for Local Screening (PRLS) for a designated language, as agreed with the line manager

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • 10–12 years of work experience in pharmacovigilance • Excellent written and verbal communication skills • Organization skills, including attention to detail and multitasking • Delegation skills • Planning and time management • Technical skills • Team working • Fluent spoken and written English • Advanced literacy in MS Office

🏖️ Benefits

• Remote work option • Collaborative and supportive team environment • Flexible work culture • Growth opportunities • Belonging and inclusive workplace culture • Passionate team of experts in clinical research, pharmacovigilance, and quality consulting

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