* Candidate has to receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards.
* Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case
* Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.
* Liaise with local Quintiles offices to facilitate expedited reporting. * Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.
* Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Industry: Pharma / Biotech / Clinical Research
Experience: 3 – 8 Years
Interested candidates can walkin on 22nd October 2016 from 8.30 am with updated resume
Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block, Wing B
Sarjapur-Marathalli Outer Ring Road,
* Candidate must have excellent knowledge of Lifecycle Safety processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
* Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs)
* Excellent written and verbal communication and report writing skills.
* Ability to be flexible and receptive to changing process demands.
QuintilesIMS’s talented professionals across the globe help clients create solutions that drive healthcare forward to advance clinical outcomes and commercial performance. Our employees are passionate about channeling their insights, commercial and scientific depth, and executional expertise to help improve health outcomes for patients around the globe.
Recruiter Name: Anju/Roshini
Email Address: email@example.com, firstname.lastname@example.org