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2018-06-27 15:15:20 Full Time

0

NA

Pharmacovigilance & Clinical Development - B.pharm/ M.pharm & Pharm D (Walk In)

Description




Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s) Participates in the selection of study vendors for assigned studies Reviews and refines clinical operational plans including the study monitoring at CRO site for all BE studies Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed. Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports. Develop and manage study timelines Participates in the selection of investigational sites with input from Clinical/Medical Operations and vendors Assists with protocol synopsis design and medical issue resolution Proactively identifies project risks and resolves with some supervision Participates in study data review and other review activities as assigned Oversees clinical trial sites adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel Oversees the submission of trial-related and essential documents to the Trial Master File Identifies and provides solutions to clinical trial issues and/or risks Represents Clinical Operations in cross-functional initiatives, as assigned by Line Manager, and may act on behalf of team when designated Work closely with other teams in the organization, e.g. quality, regulatory, etc. Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested Should be well versed with Indian pharmaco-vigilance system and guidelines Should be well aware of ADR reporting system in Indian context Review of annoymised single patient reports & Individual case safety reports Should prepare & review of periodic safety update reports. Should be able to prepare Risk Mitigation Plans Should be able to prepare Expert reports. Should be able to review & comment on adverse event cases from various countries Should be able to provide medical comments on expectedness & unexpectedness of the adverse events for expediting cases. Review of the pharmaco-vigilance agreement with the export partners of RPG

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Openings : 1

Closed
JOB ID

TH2018411

EXPERIENCE

Fresher To 1 years

VALID TILL

Jun 27, 2018 To Jul 27, 2018

LOCATION

Hyderabad(Ameerpet), Vijayawada, Warangal NA NA NA NA

REQUIRED SKILLS CTC

Upto 4,50,000 NA K Per Annum

ROLE

Documentation/Medical Writing

CONTACT PERSON

CONTACT NUMBER

CONTACT TIME

10:00am - 05:00pm

GR