Pharmacovigilance Project Manager

Posted 3 Days Ago
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Hiring Remotely in Madrid, Comunidad de Madrid
In-Office or Remote
Mid level
Biotech • Pharmaceutical
The Role
The Pharmacovigilance Project Manager acts as the primary contact for project matters, ensuring client satisfaction, managing project activities, and preparing reports for clients and management.
Summary Generated by Built In
Company Description

We are PrimeVigilance (part of Ergomed PLC), 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

  • Acting as the primary contact point for project-related matters 

  • Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations. 

  • Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance. 

  • Project activities planning, including deadlines and interim milestones 

  • Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing. 

Qualifications

  • Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs, writing, or contributing to aggregate reports, literature screening, reconciliation, and preparation of SOPs 

  • PV Project Management experience from ideally a service provide / CRO 

  • Health Care Professional or Life Science Graduate 

  • Be comfortable with communicating at senior levels within pharmaceutical organizations 

  • Have good leadership qualities including skills in planning, mentoring, meeting facilitation, communication and problem solving. 

 

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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