Medical Reviewer I

2 tygodni temu

Warsaw, Polska PrimeVigilance Pełny etat
Job Description

The Medical Reviewer I is responsible for medical review of lCSRs and literature review, writing of signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.

 

Responsibilities include:

  • To review and approve post-marketing Individual Case Safety Reports (lCSRs) 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, follow-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

Qualifications

  • 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


Additional Information

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.    

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

  • Medical Reviewer II

    2 tygodni temu

    Warsaw, Polska PrimeVigilance Pełny etat

    Job DescriptionThe Medical Reviewer II is responsible for medical review of lCSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.For the Client:To review and approve post-marketing Individual Case Safety Reports (ICSRs) and...

  • Medical Reviewer II

    1 miesiąc temu

    Warsaw, Polska PrimeVigilance Pełny etat

    Job DescriptionFor the Client:To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.To act as a...

  • Credit Risk Manager

    6 miesięcy temu

    Warsaw, Polska Randstad Polska Pełny etat

    Apply for the position Credit Risk Manager and join an international bank! what we offerPrivate medical careSubsidy for means of transportLunch card International environment Employment contract your tasksBring strong local knowledge, lending assessment skills and experience to thecredit review and management process Assess the overall creditworthiness...

  • IVDR Product Assessor

    2 miesięcy temu

    Warsaw, Polska SGS Pełny etat

    Job Description As an  IVDR Product Assessor , you will use your skills as an expert in  clinical diagnostic technologies  to ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition...

  • IVDR Product Assessor

    5 miesięcy temu

    Warsaw, Polska SGS Pełny etat

    Job DescriptionAs an IVDR Product Assessor, you will use your skills as an expert in clinical diagnostic technologies to ensure that patients across Europe have access to safe and effective diagnostic tests. Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the...

  • Audit Manager – Technology Infrastructure

    5 miesięcy temu

    Warsaw, Polska 11101 Citibank Europe plc Poland Pełny etat

    Post location: Warsaw, Prosta 36, Citi Solutions Center Role Overview: The Audit Manager is responsible for performing moderately complex audits and assessments of Citi’s risk and control environments in coordination with the global Audit team . The overall objective is to utilize in-depth subject matter expertise to ensure that the firm meets...

  • Audit Manager

    6 miesięcy temu

    Warsaw, Polska 11101 Citibank Europe plc Poland Pełny etat

    Location : Warsaw, Prosta 36 About the Team: Our Warsaw-based Internal Audit is a global organization, which sits within Citi Solution Center as one of its key components with over 1600 professionals across continents covering Citi's global businesses and services. IA is a change agent within Citi aimed to enhance the control culture of...

  • Principal Data Engineer

    6 miesięcy temu

    Warsaw, Polska Bayer Pełny etat

    At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...