Covance Drug Safety Coordinator in Bangalore, India

Job Overview

Work Location: Bangalore

Train and mentor the PV&DSS Support Specialists to provide a smoothly running department. Ensure that expeditable adverse events are processed to the required standard and submitted to the client and the regulatory agencies (if required) within the agreed/stated timelines.

Responsible for providing this service to clients either as a support function to the client project groups or as stand-alone business.

Responsibility to provide all clients, both internal and external with the appropriate quality of service in a safe and cost-effect manner.

He/she will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual

Essential Job Duties:

  • 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

  • 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. 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).

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

  • 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.

  • Coordinate shipments of safety documents.

  • Prepare and coordinate safety study files for archiving at completion of projects.

  • Arrange and schedule internal and external meetings/teleconferences.

  • Train and mentor the PV&DSS Support Specialists in their day-to-day activities.

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

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

  • Any other duties as assigned by management.



Educated to at least GCSE level or equivalent.

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



  • 2 to 5 years of experience required, safety experience preferred.

  • Supervisory experience, but not necessarily line management experience.

  • Office experience or equivalent training.

  • Ability to set priorities and handle multiple tasks.

  • Pays attention to detail.

  • Good team player.

  • Good written and verbal communication skills.

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

  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.

  • Ability to operate standard office equipment.

Job Number 2018-16987

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.