Walk-In for B.Pharm | M.Pharm | Pharm.D | Nursing | Dental Graduate Freshers on 22nd Feb' 2020 @ Bioclinica India Limited

BIOCLINICA - Walk-In for B.Pharm | M.Pharm | Pharm.D | Nursing | Dental Graduate Freshers on 22nd Feb' 2020

Walk- In at Bioclinica

Day, Date: Saturday, 22nd Feb 2020

Time: 9 AM to 1 PM 

Venue:

Bioclinica, ABBHI Campus, #120 P- 122P,

Belagola Industrial Area, K R S Road,

Metagalli, Mysore - 570 016

Job Title: Jr Drug Safety Associate

Location: Mysore

Years of Experience: 0 to 1 years
Education: B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc Nursing, MSc Nursing

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 with regulatory &pharmacovigilanceguidelines.

·         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.

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