Medical Writer (Pharmacovigilance)

PrimeVigilance

Praha
Trvalý pracovní poměr
Plný úvazek

Před 19 dny
Snadno podejte žádost

Company DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.Job DescriptionWe are looking for a pharmacovigilance medical writer to join our team. The Medical Writer will be responsible for medical writing including:

PSURs/PBRERs
PADERs
ACOs
DSURs
RMPs
QC and review of all written output from the operations team as required
Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
Complete quality documentation of aggregate reports
Attending kick off meetings with new clients as required
Attending audits and inspections as required
Providing aggregate report training

Qualifications

MD, pharmacy or Life Science degree (Masters or PhD is desirable)
Strong previous experience in Pharmacovigilance (case processing, signal detection or risk management) within ideally 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

Additional InformationWhy PrimeVigilanceWe 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.

PrimeVigilance