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 products 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.
Remote Work: No
Employment Type: Full-time
Key Skills
Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research ExperienceDocument Management Systems,Word Processing,Writing Skills
Experience: years
Vacancy: 1
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