Senior Pharmacovigilance Associate

Job not on LinkedIn

🔥 2 hours ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 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

• Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific 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 • Handle personal data protection requirements • Handle Product Quality Complaints and interact with Quality Assurance • Interact with Medical Information • Perform MedDRA and WHO coding • Produce database outputs and reports, including data for monthly client reporting • Manage workflow and resources • Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients • Perform tasks assigned under SOPs to more junior positions • Support the RA & PV Network Department as needed • Act as LCPPV (Local Contact Person for Pharmacovigilance) for the specified country when assigned • Act as PRLS (Person Responsible for Local Screening) for the designated language when assigned

🎯 Requirements

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance • Minimum 1 year of work experience in pharmacovigilance • Organization skills, including attention to detail and multitasking • Management skills, including time and issue management • English - advanced (spoken, written) • Advanced literacy (MS Office)

🏖️ Benefits

• Remote work option • Flexible work environment • Growth opportunities • Collaborative team environment • Diverse and inclusive workplace • Belonging-focused culture • Work with global teams across Europe, North America, South America, Asia and Australia • Opportunity to contribute to patient safety and pharmaceutical treatment • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting

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