Associate Case Processing Manager (Line Management position)

Reposted 5 Days Ago
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Praha, Hlavní město Praha
Hybrid
Senior level
Biotech • Pharmaceutical
The Role
Leads the team managing ICSR for projects, ensures task distribution, oversees workflow, supports project activities, and engages in team management and quality control.
Summary Generated by Built In
Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

  • Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader 

  • Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process 

  • Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management 

​​Role and Responsibilities​ 

  • Providing support to other activities undertaken by the project team on behalf of the client and the company 

  • Line Manages assigned ICSR staff 

  • Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) 

  • Proposes process changes to ICSR Operational Lead 

  • Manages ICSR deviations with ICSR Operational Lead support 

  • Reviews trackers and timesheet data and ensures accuracy 

  • Is involved in ICSR processing and 2nd QC of cases 

  • Operates as the assigned team SME and supports other SMEs 

Qualifications

Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance 

Extensive experience in pharmacovigilance within which demonstrated work experience in line manager role. 

  • Excellent communication (written and verbal) skills 

  • Organization skills, including attention to details and multitasking 

  • Delegation skills 

  • Planning and time management 

  • Technical skills 

  • Team working 

Additional Information

Why PrimeVigilance? 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

  • Training and career development opportunities internally  
  • Strong emphasis on personal and professional growth 
  • Friendly, supportive working environment 
  • Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!  

  • Quality 
  • Integrity & Trust  
  • Drive & Passion  
  • Agility & Responsiveness  
  • Belonging 
  • Collaborative Partnerships  

We look forward to welcoming your application. 

Top Skills

Medical Information
Pharmacovigilance
Quality Assurance
Regulatory Affairs
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The Company
HQ: Raleigh, NC
535 Employees
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.

• 1,400+ highly qualified professionals
• Global full-service CRO
• 25+ years of experience
• Therapeutic specialization in oncology
• Strong expertise in rare disease trials
• Robust clinical safety system
• Choice of leading drug safety databases

Our key services include:
• Clinical Research Services
• Pharmacovigilance
• Medical Information
• Regulatory
• Medical Writing
• Site Management
• Study Physician Support
• Biostatistics
• Patient Study Support

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