Senior PV Associate

  • Sofia, Bulgaria
  • Employees can work remotely
  • Full-time

Company Description

PrimeVigilance, an Ergomed brand, was established  to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with  its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.  This success is due to the hard work of our highly skilled employees and our subsequent  reputation for excellence with our clients. 

Job Description

Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management

Contributes to achieving company´s goals and objectives

Works under supervision of more experienced colleague

Providing support to other activities undertaken by the project team on behalf of the client and the company

Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):

Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines

·       Performing ICSR follow up

·         SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)

·         Reconciliation (clinical, partners)

·         Product Quality Complaint handling and interaction with Quality Assurance

·         Medical Information interaction

·         Database Outputs and Reports (including data for monthly reporting to clients)

 

 

 

Qualifications

We expect:

  • Degree educated in a Life Sciences subject
  • Interested in pursuing a career in pharmacovigilance
  • Fleuncy in Finnish and English
  • Knowledge of additional foreign language is an advantage
  • Good IT skills (MS Office)
  • People who are excited to learn and contribute to patient safety
  • Excellent organization skills with attention to detail
  • Excellent interpersonal and communication skills

Additional Information

We offer:

  • Full-time position
  • Pharmacovigilance and other professional trainings
  • Various directions of career development
  • Competitive salary and benefits
  • Very interesting job within a friendly international (EU) team of young highly educated people

If you would like to be considered for this opportunity, please send your application electronically enclosing your English CV. Due to high a volume of applications only short-listed candidates will be contacted.

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