Career as Safety Processing Expert in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Safety Processing Expert

Job Description
(State in one sentence the overall objective of the role) Responsible for the receipt, acknowledgment, tracking and archiving of single case safety reports incoming from Novartis Country Pharma Organisations and license partners.
Major Activities (Describe main activities)
1. Performs initial checks, triages, tracks and acknowledges received safety reports in the DS&E tracking tool.
2. Maintains the case safety files by accurate indexing, filing and archiving in secure storage.
3. Retrieval of source documents as required.
4. Coordinate and document exchange of safety data with license partners and Clinical Research Organisations
5. Assist with administrative and procedural activities as required or requested.
6. Assists in the training of other Safety Data Associates as necessary. Key Performance Indicators (Indicate how performance for this role will be measured)
1. Timely and high quality completion of safety administrator deliverables, according to established objectives. Impact on the organization:
• Single case regulatory reports need to be processed and filed quickly and accurately to ensure the department maintains it’s regulatory and SOP compliance.

Manage daily operation and complete the task as per require TAT
Ability to learn quickly Number, timelines and scientific quality of deliverables according to established directives Consistent demonstration of company values/behaviors

Candidate Profile
Minimum: Medical Degree (MBBS) or Bachelor Degree in Pharmacy or Advanced Nursing Degree or Master Degree in life sciences or related fields; or equivalent combination in educational credentials and Good knowledge/fluency in English. Knowledge of other languages desirable. 1-2 years of prior experience in Pharmacovigilance or clinical trials. Familiarity with medical terminology.
• Ability to write clearly and concisely.
• Self-motivation and proactive stance to work.
• Sense of urgency and commitment for timely completion of activities.
• Prior Medical Transcription or Medical Writing experience preferred.
• Previous data entry experience is desirable

Additional Information:
Qualification: B.Pharm or MBBS, Master Degree in life sciences
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 178689BR
End Date: 30^th December, 2015