Drug Safety Associate 1

We are hiring!!

Open Position : Drug Safety Associate - 1, with a minimum of 1 year experience in case processing.

Location

Salary Upto :

Qualifications:

Education: Health care professional or Any Equivalent Degree (B pharm/M Pharm/ Pharm D)

Experience: 1 to 2 years of experience in PV (Pharmacovigilance)

Roles 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 Drug 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 crossdepartment 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.

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.

Additional Skills

• Strong motivational skills and abilities, promoting a team-based approach.
• Strong interpersonal and communication skills, both verbal and written.
• Strong organizational and leadership skills.
• Goal-oriente and ability to maintain professional and positive attitude.