Bioclinica India is hiring experienced Drug Safety professionals for ICSR Case processing.
The work location is Mysore.
The title will commensurate with experience and company policy.
Post Name: Drug Safety Professionals
Qualification : Must be a graduate in Pharmacy (B Pharmacy, M Pharamcy, Pharm D, BDS)
Experience : Minimum 1 to 3 years experience in ICSR case processing.
Job Location: Mysore
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.
- 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
- Understanding of Patient Safety regulatory obligation
- Good attention to detail
- Ability to deliver within established timelines
- Fluency in Spoken and written English and excellent comprehension
- Strong motivational skills and abilities, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and leadership skills
- Ability to maintain professional and positive attitude