Senior Medical Writer I

16 hours ago

Bucharest, Bucureşti, Romania PrimeVigilance Full time €30,000 - €60,000 per year

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 PrimeVigilance Senior Medical Writer role offers a unique opportunity to further develop your career in the field of drug safety. You will be working in an international team of experienced aggregate report writers, contributing to further departmental growth.

Key Responsibilities

  • Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product's life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
  • Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
  • Support in all pharmacovigilance operations associated with medical writing
  • Continuous self-education in all aspects associated with medical writing
  • Managing a team of junior medical writers

Qualifications

  • Life Science degree- PhD or Masters qualification is desirable
  • Strong years of experience in full PV aggregate report writing- DSURs, PSURs, RMPs and ACOs etc
  • Previous experience required and PV and working in a CRO/Service provider ideally
  • Line Management Experience
  • Excellent communication skills in English, additional languages are desirable

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.

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