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Job Opportunity for Patient Safety-Associate in TATA Consultancy Services -Team Member

Job Description

Manage safety data, by processing AE cases of low to medium business risk and/or developing skills in Safety Surveillance or Support activities

Responsibilities:

•Enter initial and follow-up information for individual adverse event case reports of low business risk onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry and Process Instructions and associated SOPs and Working Instructions, to ensure consistency of case entry and high data quality standards

•Perform QRE on cases of low business risk

•Identify and request appropriate follow up information on cases in consultation with the DS Physician and other DS personnel to ensure all cases meet the needs of internal and external customers

•Perform all activities within the required timeframes to ensure regulatory compliance

•Handle questions and correction requests for own cases from other Data Entry Sites.

•Ensure that the appropriate Patient Safety Physician is made aware of any adverse event which may have medical, regulatory, legal or other consequences so that it can be managed in accordance with procedures

•Maintain well-documented paper files for each case to provide an audit trail in order to satisfy the requirements of any regulatory inspection

•Support a performance-driven culture

•Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures

Minimum Requirements –Education and Experience

•Qualified to degree level in biosciences or an appropriate healthcare or pharmaceutical industry background

•Basic competence with medical and therapeutic terminology

•Able to work independently, guided by procedures, with appropriate support

•Able to work effectively as part of a team

•An understanding of the international regulatory requirements for single case expedited reporting and periodic updates

•Demonstrable communication skills

•Maintains high ethical standards, including a commitment to Client's values and behaviours

•Good attention to detail

•Good time management

•Fluent in English

•Computer literate

Basic Requirements:

Min’ 15yrs of academic qualification 
Willingness to work across shifts.

If you are interested : Please Walkin with a hard copy of your CV, copy of last 2 months pay slips  and one passport size photograph (Mandatory).

Work Location :   Mumbai

Venue:

TATA Consultancy Services,
Godrej & Boyce complex,
Gate No 4, Plant No 12,
L.B.S. Marg, Vikhroli (West)
Mumbai - 400079,Maharashtra
India


Day:

Monday 24th Nov 2008  –  Friday 28th Nov 2008

Registration Time:

11.00AM – 4.00 PM

Contact Person:  Vahbiz K Shroff

Note:

Should have 15 years of Regular Education

Break in career and education for more then 2 years is not eligible

Candidates who have attended the selection process in the last 6 months (either selected-not-joined or rejected) will not be eligible.

*** The entire selection process to complete requires you to appropriately block your day, request all to plan your schedule.

All the very best!!!

Talent Acquisition Group

Tata Consultancy Services

Additional Information   
      
Experience :     1 - 4 years   
    
Education :    BDS, B.Pharm, B.Sc, MBBS, M.Pharm, M.Sc   
    
Job Category:     • Pharmaceutical/ Biotechnology • Health Care   
    
Job Location :      Mumbai   
    
Key Skills:    Pharma Covigilence,Regulatory Affairs, Drug Safety, Safety Data Manager, Drug Regulatory, Clinical Research   
    
Job Ref code:    01   
    
Role:    • Drug Regulatory Doctor • Quality Assurance/ Control • Other Pharma • Other Health Care/ Hostpitals