PV Officer (HCP and CT experience) senior level

Ergomed

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profile Job Location:

Sofia - Bulgaria

profile Monthly Salary: Not Disclosed
Posted on: 12 hours ago
Vacancies: 1 Vacancy

Job Summary

At PrimeVigilance PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.  

If you join PrimeVigilance you can expect to work with teams of different sizes from small clinical trial to large generic post-marketing teams. We are always looking for proactive capable and motivated individuals who aim to surpass any target set in front of them. 

The PV Officer should be a HCP or have other healthcare related degree qualification (Pharmacy MD nursing etc.) and have demonstrated experience in case processing.

The PV Officer will be working as part of a project team performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.  PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team following onboarding completion. 

Responsibilities include:  

  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials including device and combination products) in compliance with applicable regulations PrimeVigilance procedures and in accordance with client specific requirements and timelines. As a key member there is an expectation to effectively cover all steps of a workflow cycle except Medical Review. 

  • Independent SAE/SUSAR Management (submissions unblinding clinical trial reconciliations)  

  • Preparation of database outputs for periodic reporting (PBRER DSUR PADER etc.) 

  • Mentoring and training of new and more junior employees within the department including procedure optimization and development 

 


Qualifications :

  • HCP Life science / bio medical background healthcare related degree    

  • Demonstrated case processing experience 

  • ARGUS experience preferred  

  • Time and issue management delegation organization and multitasking skills with good attention to detail   

  • Strong interpersonal and communication skills   

  • Advanced English skills both verbal and written at least C1  


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. 

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company possibility for your quick career growth
  • Multicultural environment English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance internal trainings provided by skilled professionals but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year

 

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  

We look forward to welcoming your application. 


Remote Work :

Yes


Employment Type :

Full-time

At PrimeVigilance PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.  If you join PrimeVigilance you can expect to work with teams of different sizes from small clinical trial to large generic post-marke...
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About Company

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Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more

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