BIOCLINICA - Freshers & Experienced Walk-In @ Bangalore near Basavanagudi on 3rd Nov' 2018

Walk-In for Freshers & Experienced @ our Bangalore office on 3rd Nov, 2018 (Saturday)

This role is into Pharmacovigilance domain and the walk-In timings are in between 9 AM – 1 PM.

Walk-In Venue:

Bioclinica India Pvt. Ltd,

#18/2 & 18/3, V G Heritage,

Vanivilas road,

Basavanagudi,

Bangalore.

Kindly go through the job description and walk-in with your updated resume.

JOB TITLE: Drug Safety Associate

LOCATION: Mysore, India

YEARS OF EXPERIENCE: 0 to 2 years

EDUCATION: Any Health care professional (BPharm/M Pharm/ Pharm D/B. Sc Nursing / BPT / BDS / BHMS / BAMS etc.)

Essential Duties and Responsibilities:

As Case Intake Member:

· Responsible for case intake, duplicate check, and registration

· Maintain log of source documents and other communications

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.

As Literature Review Specialist

· Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.

· Review of literature articles to identify case safety reports.

· Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.

· Assist in signal generation and safety analysis activities.

· Ensure quality of literature searches and reporting.

· Review of local/global literature reports to determine regional reportability.

· Create/maintain study summary documents.

· Assist with narrative writing for periodic/ad hoc submissions.

· Assist with ad hoc or routine safety monitoring activities.

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

· Perform any other drug safety related activities as assigned

· Perform literature review activities when trained and 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 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.

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.

Willing to work in shifts as and when needed