BIOCLINICA – Pharmacovigilance jobs | Sr. Drug safety associate

Company name – BIOCLINICA

Location – Mysore

Position – Sr. Drug Safety Associate ( PHARMACOVIGILANCE)

Job Description

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.

Application Link –

https://bioclinica.wd1.myworkdayjobs.com/en-US/Bioclinica_careers/job/Mysore-India/Sr-Drug-Safety-Associate_R7048?source=Linkedin