Post : Drug Safety Associate
Job Description
As Case Processor:
• Responsible for data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures
• Process all incoming cases in order to meet timelines
• Full data entry including medical coding and safety narrative
As Case Processor:
• Responsible for data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures
• Process all incoming cases in order to meet timelines
• Full data entry including medical coding and safety narrative
As Medical Coder
• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
• As Narrative Writer
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
• As Narrative Writer
• Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
As Call Handler
• Handles all product‐specific complaints/inquiries and listens to voicemail recordings
• Performs outbound call follow‐up to obtain missing or additional details.
• Enters PC/Inquires in Synowledge PC tools
• Handles all product‐specific complaints/inquiries and listens to voicemail recordings
• Performs outbound call follow‐up to obtain missing or additional details.
• Enters PC/Inquires in Synowledge PC tools
Other Responsibilities:
• Following up with sites regarding outstanding queries.
• Follow-up on reconciliation of discrepancies.
• Follow departmental AE workflow procedures.
• Closure and deletion of cases.
• Perform submission activities when trained and assigned.
• Understanding and application of good documentation.
• Perform any other drug safety related activities as assigned.
• Following up with sites regarding outstanding queries.
• Follow-up on reconciliation of discrepancies.
• Follow departmental AE workflow procedures.
• Closure and deletion of cases.
• Perform submission activities when trained and assigned.
• Understanding and application of good documentation.
• Perform any other drug safety related activities as assigned.
Knowledge and Skills:
• Basic competence with medical and therapeutic terminology.
• Ability to work independently but guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Understanding of patient safety regulatory obligations.
• Should be familiar regulatory &Pharmacovigilance guidelines.
• Should be familiar with Pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications
• Basic competence with medical and therapeutic terminology.
• Ability to work independently but guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Understanding of patient safety regulatory obligations.
• Should be familiar regulatory &Pharmacovigilance guidelines.
• Should be familiar with Pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications
Candidate Profile
• Qualified to Degree Level in Biosciences or an Appropriate Healthcare or Pharmaceutical Industry
• Background Communication Skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross‑ departmental communication. Ability to document and communicate problem/resolution and information/ action plans.
• Qualified to Degree Level in Biosciences or an Appropriate Healthcare or Pharmaceutical Industry
• Background Communication Skills: Requires a proactive approach and excellent written/oral communication and interpersonal skills.
• Strong interpersonal skills required to interact with clients, management, and peers effectively.
• Effective cross‑ departmental communication. Ability to document and communicate problem/resolution and information/ action plans.
Additional Information
Experience : 3-4 years
Qualification : B.Pharm, M.Pharm
Location : Mysore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : MICC
End Date : 5th February, 2019
Experience : 3-4 years
Qualification : B.Pharm, M.Pharm
Location : Mysore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : MICC
End Date : 5th February, 2019
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