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Novartis

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4.1

based on 1.6k Reviews

279 Novartis Jobs

Senior Safety Case Expert

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.6k Reviews

3-5 years

Hyderabad / Secunderabad

1 vacancy

Senior Safety Case Expert

Novartis

posted 5hr ago

Job Role Insights

Flexible timing

Key skills for the job

Data Entry Pharmacy Pharmacovigilance Operations Clinical Data Management Life Sciences

+ 4 more

Job Description

Summary

Responsible to ensure case processing and ancillary activities in compliance with PS&PV business rules, standard operating procedures and regulatory requirements. Responsible for preparation and maintenance of manuals and other relevant/assigned documents Subject matter expert for cross-sub functional projects within PS&PV
Lead implementation of new process and process amendments/changes

About the Role

M a j o r A c c o un t a b i l i t i es

Monitor all case processing related activities to facilitate oversight on External Service Providers ( ESP s ) quality and compliance of deliverables

Evaluation and QC of Serious Adverse Event / Post Marketing Adverse Event to ensure accurate and consistent data entry and processing from source documents, with emphasis on accuracy, timeliness and quality . Perform Argus data entry as needed.

Perform daily quality review (QR) for Individual Case Safety Reports (ICSR) by comparing source documents and the case information entered the safety database to ensure accurate and consistent data entry/quality. C oach /Train/ Mentor other team members including ESPs , as required

Lead/support the process changes according to internal and externals drivers, including development and monitoring of process related metrics

Lead the preparation and maintenance of manuals and other relevant/assigned documents

Participate in the creation and maintenance of training material and communications for Novartis and ESPs.

Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and
other Global Line Functions on regulatory requirements and assigned business process.

Develop, contribute and maintain guidance documents including providing inputs to Vigilance Agreement ( VA ) and other such safety management plans

Support in audits/inspection as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings

Assess and analyze case processing related queries from Health Authorities and prepare and share the responses within the timelines.

Support in-collaboration with other functions within PS&PV to facilitate process improvements

Collaborate with Data Management team to enable reconciliation for locking of Clinical database

Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.

Work with Novartis country safety departments, License partners and medical function to ensure that reports are accurately collected, evaluated and data based. Lead the testing activities for case processing related safety systems/IT applications .

Lead PS&PV Operational Projects and support high complex/critical projects or database validation activities as required .

Minimum Requirements:

Graduate/Postgraduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. 8+yrs of Industrial experience with 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
Good professional verbal and nonverbal communication skills
Experience in Document writing desirable
Self-motivation and proactive stance to work
Sense of urgency and commitment for timely completion of activities
Previous Pharmacovigilance data entry experience is desirable.
Strong negotiation and ability to operate effectively in a global environment and across line functions.