PV Assistant

Posted 2 Days Ago
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Niš, Nišavski, Centralna Srbija, SRB
In-Office
Entry level
Biotech • Pharmaceutical
The Role
Process, track and file Individual Case Safety Reports (ICSRs); ensure activities meet regulatory, PrimeVigilance and client timelines; act as local pharmacovigilance contact and person responsible for local screening; handle safety messages, receipts, and administrative tasks while maintaining confidentiality and accuracy.
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

  • Process, track, and file standard Individual Case Safety Reports from all sources.
  • Ensure all activities meet regulatory, PrimeVigilance, and client timelines.
  • Serve as the Local Contact Person for Pharmacovigilance and Person Responsible for Local Screening.
  • Handle safety messages, receipts, and other administrative tasks as needed.

Qualifications

  • High school or university graduateAdvanced
  • English skills, both verbal and written, at least B2 
  • Desirable administrative experience and good IT skills (MS Office) 
  • A high degree of discretion dealing with confidential information 
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail 
  • Ability to work under pressure with accuracy and meet tight deadlines 
  • Good interpersonal and communication skills 

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.

Skills Required

  • High school or university graduate
  • English language skills at B2 level or higher (verbal and written)
  • Administrative experience
  • Good IT skills (MS Office)
  • High degree of discretion when handling confidential information
  • Ability to manage multiple varied tasks and prioritize with attention to detail
  • Ability to work under pressure with accuracy and meet tight deadlines
  • Good interpersonal and communication skills
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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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