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初级药物警戒专员

雇主

Ergomed

地点

远程 · Remote · 西班牙

待遇

€面议

工作模式

远程

截止日期

1月5日

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岗位摘要

The Junior PV Officer role is a mid senior role that requires previous experience in Pharmacovigilance case processing.

岗位职责

The Junior PV Officer role is a mid senior role that requires previous experience in Pharmacovigilance case processing. It includes:
Providing support to other activities undertaken by the project team on behalf of the client and the company
Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
Processing Individual Case Safety Reports(ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
Performing ICSR follow up
SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
Reconciliation (clinical, partners)
Personal data protection
Product Quality Complainthandling and interaction with Quality Assurance
Medical Information interaction
MedDRA and WHO coding
Database Outputs and Reports (including data for monthly reporting to clients)
Workflow & resource management
Mentoring and training of new and more junior employees within the department
Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
More senior colleague may perform tasks assigned as per SOP to more junior position
Performing activities in the scope of ICSR management unit within agreed extent and timeframe
Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager
Requirements:
Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance
Excellent communication (written and verbal) skills
Organization skills, including attention to details and multitasking
Delegation skills
Planning and time management
Technical skills
Team working
Advanced literacy (MS Office)
English – fluent (spoken, written)
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality:we hold ourselves to the standard patients deserve.
Integrity and trust: we do the right thing, especially when it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
Agility and responsiveness: we move quickly, because patients cannot wait.
Belonging:everyone is welcome, and every voice counts.
Collaborative partnerships: we go further by going together.
We look forward to welcoming your application.
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
Originally posted on Himalayas

申请条件

生命科学/生物医学背景——医疗相关学位(化学、生物学、生物技术、兽医学)并有药物警戒方面的实际经验
优秀的沟通(书面和口头)能力
组织能力,包括注重细节和多任务处理能力
具备药物警戒病例处理经验
能够按照适用法规、公司程序和客户特定要求及时间节点处理ICSR
能够执行ICSR随访
具备SAE/SUSAR管理能力(揭盲、临床试验对账、方案审查、安全管理计划审查)
具备对账能力(临床、合作伙伴)
了解个人数据保护
具备产品质量投诉处理及与质量保证部门互动的能力
具备医学信息互动能力
具备MedDRA和WHO编码能力
能够处理数据库输出和报告(包括向客户提交的月度报告数据)
具备工作流程和资源管理能力
能够指导和培训新员工及较初级员工
能够支持与ICSR管理相关的药物警戒流程
能够根据需要支持RA与PV网络部门,包括担任指定国家的LCPPV以及指定语言的PRLS
能够完成SOP分配给较初级岗位的较高级别同事任务

雇主简介

Ergomed是一家提供临床研究服务的合同研究组织(CRO),专注于帮助制药公司开发和上市安全有效的药物,尤其在肿瘤和罕见病治疗领域。

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数据来源:Himalayas

岗位信息来源于公开渠道,版权归原作者所有