Clario (Bioclinica) Pharmacovigilance Drug safety Associate Job Openings India

Clario Pharmacovigilance Drug Safety Associate I Job Openings in India. interested & Eligible Candidates apply Now

locations : Mysore, India
type : Full time

Essential Duties and Responsibilities:

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.

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‑department communication.
• Ability to document and communicate problem/resolution and information/action plans.

Desired technical skills:
Person should be familiar with MS Office Tools.
Safety database knowledge.

Other skills:

• The ability to contribute to a team environment with a high degree of professionalism and skill.
• Demonstrate flexibility within a dynamic, fast-paced, cross-functional team.
• Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
• Ability to perform under stringent timelines.

Compliance:

• Awareness of organizational policies & procedures governing his/her job responsibilities.
• Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level.
• Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.

Working Conditions: Normal office environment.

Hours:

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

Clinical Research opening for all Lifesciences Candidates