Covance Safety Science Analyst in Bangalore, India

Job Overview

  • Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:

  • maintenance of adverse event tracking systems.

  • set-up and maintenance of project files, core process files and central safety files.

  • assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.

  • Provide administrative support to PV&DSS personnel (e.g. word processing, proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).

  • Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA).

  • Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA)/Sr. DSA.

  • Assist in the maintenance of files regarding adverse event reporting requirements in all countries.

  • Maintain and distribute a weekly schedule for PV&DSS staff.

  • Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).

  • Build and maintain good PV&DSS relationships across functional units.

  • Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).

  • Assist the DSA/Sr. DSA in preparation of materials needed for client and/or investigator meetings.

Any other duties as assigned by management.

Education/Qualifications

Required:

Educated to at least GCSE level or equivalent.

H.S. diploma or equivalent, some college preferred.

Experience

  • 2 years of office experience.

  • Attention to detail.

  • Team player.

  • Solid written and verbal communication skills.

  • Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.

  • Knowledge of MS office Windows applications beneficial.

Ability to operate standard office equipment.

Job Number 2018-20635

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.