Medical Writer III - Pharmacovigilance

Medical Writer III - Pharmacovigilance

PrimeVigilance

Lisbon, Portugal

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

• Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
• 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

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