Medical Writer Specialist

1 miesiąc temu


Warszawa, Mazovia, Polska PrimeVigilance Pełny etat

Medical Writer Job Description

**About the Role**

We are seeking a highly skilled Medical Writer to join our team at PrimeVigilance. As a Medical Writer, you will be responsible for creating high-quality medical content, including reports, documents, and other materials.

**Key Responsibilities**

* Create medical writing content, including PSURs, PBRERs, PADERs, ACOs, DSURs, RMPs, and other regulatory documents
* Review and edit written output from the operations team to ensure accuracy and quality
* Collaborate with project managers to determine scheduling of aggregate reports
* Identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
* Complete quality documentation of aggregate reports
* Attend kick-off meetings with new clients and audits/inspections as required
* Provide aggregate report training

**Requirements**

* MD, pharmacy, or Life Science degree (Masters or PhD is desirable)
* Strong previous experience in Pharmacovigilance (case processing, signal detection, or risk management) within a CRO environment
* Ability to manage multiple and varied tasks and prioritize workload with attention to detail
* Ability to effectively train and mentor Associate Medical Writers
* Must be a strong team player
* Fluency in English, an additional language is a benefit

**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. We offer training and career development opportunities internally, a strong emphasis on personal and professional growth, a friendly and supportive working environment, and the opportunity to work with colleagues based all over the world. 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.



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