Medical Reviewer I Bucharest

Medical Reviewer I
Bucureşti
Bucharest, Bucharest, Romania

Job Description

For the Client (May include but is not limited to the following):

To review and approve
- marketing Individual Case Safety Reports (l
CSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and company causality, as well as writing of company comment,
- up questions and analysis of similar events, when required. Including completion of all required supporting documentation such as trackers.

To review literature screening search strategy

To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product

or other safety related findings

Reviewing database outputs

To review and provide input in Periodic Safety Update Reports

To review and provide input in Development Safety Update Reports

Participating in signal detection activities including meetings and writing signal detection reports

Proposing a course of action whenever a possible signal is identified

For the Company (This may include but is not limited to):

Writing PV Procedures

Mentoring less experienced Physicians

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance
• Any experience in aggregate reports and signal detection is desirable
• Excellent interpersonal skills
• Ability to plan, organise, prioritise and execute multiple tasks
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork
• Communication skills
• Presentation skills

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.  

#LI Remote