Benefit/Risk Associate II

Posted 7 Days Ago
Be an Early Applicant
Lisbon
Entry level
Biotech • Pharmaceutical
The Role
The Benefit/Risk Associate will participate in signal detection activities, review line listings, draft signal detection reports, maintain relevant tracking tools, and collaborate with other departments to ensure compliance with procedures and regulatory requirements.
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

The Benefit/Risk Associate should be a Life science / bio medical background graduate or have other healthcare related degree qualification (biotechnology, veterinary science etc.). The Benefit/Risk Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them 

The Benefit/Risk Associate will be responsible for: 

  • Participating in signal detection activities including set-up
  • Reviewing line listings required for preparation of signal detection report
  • Drafting signal detection reports, including quality control
  • Record keeping and maintenance of relevant tracking tools
  • Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements

Qualifications

  • Life science / bio medical background – healthcare related degree (biotechnology, veterinary science), previous experience is advantage 
  • People who are excited to learn and contribute to patient safety 
  • Time and issue management, delegation, organization and multitasking skills with good attention to detail 
  • Strong interpersonal and communication skills 
  • Advanced English skills, both verbal and written, at least B2 

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.

The Company
HQ: Raleigh, NC
535 Employees
On-site Workplace
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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