Hot Medical Reviewer

Required languages

EnglishProficient

Seniority

Mid level

Location

Prague

Type of job

Full-time

Required education

University

  • Bonuses
  • Contribution to vacations or recreational activities
  • Meal vouchers or meal contributions
  • Courses and training
  • Refreshments
  • Contributions to sport, culture or past time activities
  • Sick days
  • Company events and teambuilding

Overall Purpose of the job

Responsible for medical review and assessment of Adverse Events, within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs.


Responsibilities/Authorities 

  • Review and verify appropriate selection of adverse events from source documents and appropriate MedDRA codes
  • Review labeling and assess company causality
  • Review narrative and provide company comment in accordance with client requirements.
  • Verify consistency between the source documents and the narrative summary, if needed.
  • Acquire and maintain current knowledge of product portfolio and safety profiles of products across therapeutic areas
  • Identify, escalate and resolve case issues, co-ordinate with client therapeutic team/site for specific products or functional groups
  • Communicate and interact effectively within the team and with the client
  • Ensure Follow up for cases where required
  • Perform other drug safety related activities as assigned
  • Plan, organize, and manage daily work to meet service level timelines and deliverables
  • Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and Client policies.
  • Work with the SDL/Designee to escalate issues or tasks outside the normal scope of work.


Educational and Experience Requirements:

  • Medical Degree Required (e.g. MUDr., MBBS, M.D.)
  • Minimum 1-3 years of clinical experience
  • Experience and skills in working on computers
  • Ability to read and understand medical source documents and to summarize them in a well-written narrative 
  • Ability to work independently but guided by documented procedures, with appropriate support
  • Able to work effectively as part of a team, strong communication skills
  • Familiar with regulatory & Pharmacovigilance guidelines & Pharmacovigilance terminology
  • Ability to deliver within established timelines
  • Fluent in English; nice to have French or German
  • Proficient computer skills e.g. word processing, spreadsheets, safety database tools 
  • Proficiency in prioritizing assignments and ability to adapt to rapidly changing priorities 




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