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.
Job title : Pharmacovigilance
Responsibilities :
- Process clinical trial safety data by triaging initial and updated safety data, reviewing safety/CEVA data for inconsistencies, contacting sites with queries as needed, ensuring safety/CEVA data is corrected by site staff, ensuring translation of safety/CEVA data, entering applicable safety data into a serious adverse event (SAE) database when needed; writing narratives; coding terms, as appropriate; ensuring initial reports are sent to customers or marketing authorization holders within agreed timelines; updating narratives when updated information is received, as appropriate; liaising with customer/marketing authorization holders, executing case closure, reconciliation and preparation of events for archiving.
- Process post-marketing safety data by receiving SAE and adverse event (AE) reports from various sources; identifying SAEs and AEs from literature sources; identifying brand of suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events.
- Process regulatory safety data by assessing SAEs and advising the department on SAEs that qualify as expedited regulatory reports; advising team members on timelines, procedures and format to adopt for reporting to regulatory authorities; advising team members on changes in SAE regulatory reporting requirements in different countries; reporting SAEs to regulatory authorities when appropriate; liaising with local Quintiles offices to facilitate expedited reporting; liaising with safety lead and systems manager for regulatory tracking requirements; and maintaining and updating regulatory safety database.
- Process Clinical Event Validation and Adjudication cases in one or more of the following processes: Endpoint Adjudication Committee coordination, core laboratory coordination, and/or DMC administration and Steering Committee administration Job duties in this area include endpoint process design, including development of endpoint-related training, work flows and process documents; identification of endpoints for adjudication; ensuring (in conjunction with team members) that all required materials in support of an endpoint are obtained from the patient chart and prepared for submission; entering CEVA data into a tracking database as appropriate; management of endpoint and adjudication data, including tracking and reconciliation with Clinical Data Management; preparation and submit endpoint dossiers for adjudication; informing senior team members of progress toward endpoint objectives and any potential rate-limiting factors; and ensuring that for each reported endpoint in the clinical database, there is a matching, final endpoint adjudication.
- Participate in the review of existing core operating procedures (COPs).
- Identify and record quality problems and bring them to the attention of a senior team member.
- Interact with Physician and/or Project Medical Officer as appropriate.
- Generate status reports as required.
- Lead project start-up, with supervision.
- Draft project instructions/guidelines for project and amend when appropriate.
- Attend/present at investigator/CRA meetings.
- Liaise with PM and/or members of project team (CRAs, Data Management).
- QC of safety data.
- Ensure alert letters are submitted on time.
- All responsibilities are essential job functions unless noted as nonessential (N).
Required skills and abilities :
- General working knowledge medical terminology
- Basic knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical
- Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Good understanding of Core Operating Procedures (COPs)
- Strong organizational skills
- Good communication skills
- Ability to successfully handle many internal clients competing for attention, services and resources
- Strong computer skills using applicable word processing applications
- Demonstrated word processing and data entry skills
- Good attention to detail and accuracy
- Good interpersonal and organizational skills
- Ability to be flexible
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Eligibility : B.Sc/ M.Sc/ B.Tech/ M.Tech Bio-Chemistry/Bio-Technology/ Microbiology, B.pharma/ M.pharma
Experience : 0-5 Years
Walk-in Details :
Date : 28-Nov-2015
Registration Timings : 8 am to 9:30 am
Documents to carry Copy of this mail, Updated CV, Id proof (For experienced candidates :: last 3 months pay slip, latest compensation break up letter)
Assessment process - CV screening->Aptitude->HR Interview->Technical interview->Final interview
Contact person Kavya L / A Shamshuddin
Interview Location : Quintiles, Etamin Block, Wing B, Ground floor, Prestige Tech Park II, Outer Ring Road, Sarjapur, Bangalore - 560103
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