Medical Writer III

7 days ago


Pune, India PrimeVigilance Full time

Job DescriptionThe PrimeVigilance 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 self-education in all aspects associated with medical writing Managing a team of junior medical writers QualificationsPrevious experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing Pharmacy, Medicine or advanced Life Science degree 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 Additional InformationWe 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     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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