Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate

Bioclinica Hiring Pharmacovigilance Sr. Drug Safety Associate

Location : Mysore, India

Essential Duties and Responsibilities:

As Quality Check Reviewer

• Review data entered in safety database for completeness and accuracy.
• Provide quality feedback to team resources
• Track and maintain quality metrics

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

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.
• Mentor and guide the activities of the Dug Safety Associate.
• High level of proficiency al all workflow tasks.
• Perform any other drug safety related activities as assigned.

Specialized 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 with 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.

Working Conditions: Normal office environment.

Hours:

Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed

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