Pharmacovigilance Medical Writer II (Aggregate report writing experience required) Bucharest

Pharmacovigilance Medical Writer II (Aggregate report writing experience required)
Bucureşti
Bucharest, Bucharest, Romania

Job Description

We 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

• MD, pharmacy or Life Science degree (Masters or Ph
  D is desirable)
• Strong previous experience in Pharmacovigilance (Aggregate report writing, 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

Why Prime
Vigilance 

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a
- 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 Prime
Vigilance 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.