Safety Processing Expert - Novartis Healthcare Pvt Ltd

Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for Novartis drugs. Responsible for the receipt, tracking and init ......

Designation : Safety Processing Expert

Company : Novartis Healthcare Pvt Ltd

Experience : 1 - 6 Years

Location: Hyderabad / Secunderabad

Education: UG - B.Pharma - Pharmacy 
  PG - M.Pharma - Pharmacy,M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, Other

Job Description

Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for Novartis drugs. Responsible for the receipt, tracking and initialization of single case drug safety reports in to the safety database; accurate data entry and coding of adverse event reports and evaluation of non-expeditable reports within well defined timeframes, in compliance with DS&E business rules, standard operating procedures and regulatory requirements. Major Activities : 1. Receive information on adverse events, perform initial checks, search database to prevent du-plicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database. 2. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality. 3. Evaluate and finish processing of non-expeditable AE reports, including review for complete-ness and accuracy. 4. Use medical dictionaries and business guidances to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case. 5. Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed. 6. Alert manager to potential safety signals based on incoming case reports. 7. Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigi-lance Leaders to ensure that reports are accurately collected, evaluated and databased. 8. Assist with related administrative and procedural activities as required or requested. 9. Assists in the training of other Safety Processing Experts as necessary. 10. Support DS&E Projects or database validation activities as required. Key Performance Indicators : 1. Ability to learn quickly 2. Number, timeliness and scientific quality of deliverables according to established directives 3. Consistent demonstration of company values/behaviors


Desired Profile

Education (minimum/desirable): Minimum : Medical Degree (MBBS) or Bachelors Degree in Pharmacy or Advanced Nursing Degree or Masters Degree in life sciences or related fields; or equivalent combination in educational credentials and experience Preferred : MD or MS in Clinical Pharmacy, PhD in Life sciences or related fields Languages: Good knowledge/fluency in English. Knowledge of other languages desirable. Experience/Professional requirement: • Familiarity with medical terminology • Ability to write clearly and concisely • Self motivation and proactive stance to work • Sense of urgency and commitment for timely comple-tion of activities • Prior Medical Transcription or Medical Writing experi-ence preferred • Previous safety or clinical trial experience desirable, but not essential • Previous data entry experience desirable, but not essential

Reach Us

HR-Recruitment
Novartis Healthcare Pvt Ltd 
Ref ID : 54240BR

http://www.novartis.com/