Safety Science Analyst (Pharmacovigilance)

Covance

0 - 6 Years

Bengaluru

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

* 0-6 months 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.

* The position will be contingent worker and contractual position for 6 months.

* Ability to operate standard office equipment

* Candidates willing to work in shifts need only apply.

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