Senior Medical Writer (Pharmacovigilance aggregate reports)- Homebased in Europe
Job Description
The Prime
Vigilance Senior Medical Writer position offers a unique opportunity to further develop your career in the field of drug safety.
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
- education in all aspects associated with medical writing - Managing a team of junior medical writers
Qualifications
- Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
- Previous Line Management experience
- Life Science degree, or have equivalent nursing or medical qualifications
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to effectively train and mentor Associate Medical Writers
- Advanced knowledge of English
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a
- 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 Prime
Vigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
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