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.
• 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.
• 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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