Open Walkin for Pharmacovigilance Fresher's from 18th Apr-22nd Apr
Quintiles
0 - 0 yrs
Bengaluru/Bangalore
Salary : Not Disclosed by Recruiter
Job Description:
Open walk-in for freshers with life science graduation (M.Sc/ BDS/ B.Pharma/ M.Pharma/ Pharm.D/
BHMS/ Bio.Tech(BE)/ BAMS) from 18th Apr to 22nd Apr 2016.
Note:- This is a mass mail. Please ignore if you have attended interview for Quintiles open position in last 3 months.
Interview Details:-
Date : - 18th Apr 2016 to 22nd Apr 2016
Reporting Time : - 9:30 Am - 10:00 Am
Venue:-
Quintiles Research Pvt Ltd
Etamin Block, Wing B, 1st floor
Prestige Tech Park II,
Marathalli-Sarjapur Outer Ring Road,
Bangalore - 560103
JOB DESCRIPTION:
RESPONSIBILITIES
Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse
Events(AE)/endpoint information; determining initial/update status of incoming events; tracking
timelines for completion of event processing; distributing event information to appropriate project
personnel in the workflow for continued processing; review and preparation of endpoint
documentation; transfer of events to client and other parties as identified by operations lead;
obtaining confirmation of report receipt and track submission; and assuming workflow
responsibilities for various projects.
May assist with project workflow including database entry, quality control activities, generation of
Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with
deadline quality measurements, as directed by operations team member or manager.
Assist with administrative team support e.g. project start-up tasks, creation and maintenance of
project files, systems access requests; periodic distribution of AE listings; and shipping of
information supplies to sites as directed by senior operations team member.
May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization
holders, investigators, customers and operations team in accordance with deadlines; perform project
administrative tasks such as creation of labels using investigator list, maintenance of personal safety
files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking
and filing of submission dossiers, and distributing listings to client and/or operations team members.
Creating, maintain and track case folders; filing, retrieving and distribution of case folders to
operations team members; assisting in maintenance of document control storage and relevant
applications/systems as directed. Archiving case folders and project files after event closure;
coordination of transfer of archived material to company/customer archive storage facilities after
study closure; assisting in creation of records management processes and procedures; providing key
input to operations team on acquisition and/or upgrade of records management application/systems;
and serving as liaison between Lifecycle Safety department and records management department.
May assist with system support tasks such as utilizing design specifications, study form, and protocol
to create project specific entry specifications and annotated project forms for database under guidance
from operations lead and/or manager; creating project tracking spreadsheets and associated tracking
entry specifications; assisting in database validation through performance of user testing; performing
ad hoc database searches for operations team leads; assisting operations team member in assessing
database setup needs; assist with project phone/fax line set-up as required; escalating any
system/equipment problem.
Oversee and co-ordinate administrative support by coordinating team/department/customer/project
oversight group meetings, coordinating stationery orders, dispatching documents via courier services,
reserving meeting rooms and IT equipment; and providing administrative support where required.
Identify and record process or quality problems and bring them to the attention of a senior team member.
Provide training/mentoring to new/less experienced staff.
Participate in continuous improvement of all departmental processes and procedures by identifying
and implementing efficiencies in workflow and/or case processing.
Co-ordinate, oversee and delegate resource tasks to administrative team members as appropriate and
monitor the intake of cases and archiving process when multiple coordinators are involved.
Involvement and contribution in local/global department committees e.g. Engagement, Admin,
Quality initiatives
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good understanding of Good Clinical Practice (GCP) and International Conference on
Harmonization (ICH) guidelines Standard Operating Procedures (SOPs) and work instructions
applicable to the role.
Good working knowledge of Microsoft Office and web-based applications.
Good knowledge of medical terminology.
Strong organizational skills and time management skills.
Strong verbal/written communication skills.
Self-motivated and flexible
Excellent attention to detail and accuracy.
Ability to follow instructions/guidelines, utilize initiative and work independently.
Proven ability to multi-task, manage competing priorities and deadlines.
Ability to delegate and mentor effectively to less experienced team members.
Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
Regards,
Salary : Not Disclosed by Recruiter
Industry : Pharma / Biotech / Clinical Research
Functional Area : Other
Role Category : Other
Role : Other
Website : www.bookofcareer.com
Keyskills:
Pharmacovigilance drug safety
Desired Candidate Profile:
Education-
UG: B.Tech/B.E. - Bio-Chemistry/Bio-Technology, Biomedical, BDS - Dentistry, B.Pharma -
Pharmacy, B.Sc - Anthropology, Bio-Chemistry, Biology, Botany, Microbiology, Nursing, Zoology
PG:M.Tech - Bio-Chemistry/Bio-Technology, Biomedical, M.Sc - Anthropology, Bio-Chemistry,
Biology, Microbiology, Nursing, Zoology, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Please refer to the Job description above
Company Profile:
Quintiles
Quintiles is the world's largest provider of biopharmaceutical development and commercial
outsourcing services. We bring a fully integrated approach to build biopharma and life sciences
solutions - from pipeline through portfolio to population health â„¢. A career with Quintiles connects
you to great opportunity to achieve professional success and impact healthcare around the world.
Contact Company : Quintiles
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