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Medical Safety Expert

Medical Safety Expert

NOVARTIS

4 - 5 years

6 - 7 Lacs

hyderabad

Posted:1 week ago| Platform:

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Skills Required

process safety risk assessment operations management project management hazard identification construction safety presentation skills analysis pmi safety management people management skills clinical research safety safety audit crisis management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for drug monitoring programs, including monitoring adverse event reports, assessing product risk and relevance, monitoring the safety of clinical trials, and monitoring post-marketing programs. Participates in compliance with all legal obligations and regulations. Ensures and contributes to the identification of safety trends and indications and the assessment of risk management for the product lifecycle. Provides reliable support to clinical development teams.

About the Role

Major Accountabilities

Assistance is granted based on the needs of procurement activities, namely Monitor product safety, including documentation monitoring, individual/case medical assessments, or signal detection. Review executive literature. Assist in preparing individual inquiries to the Ministry of Health, particularly regarding short-term notification requests. Follow up on the health authorities' assessment report. Help securely implement regulatory issues and clinical documents. Support maintenance and management of local anomalies. Assist in the evaluation and preparation of other Support for new submission guidelines (legal access to document security) if necessary. Be prepared to respond to a national security request and manage an external security request. Medical Procedures/Medical Interventions Expert (PMI) Management of training and orientation of juniors/colleagues Distribution of marketing samples (if applicable)

Key Performance Indicators

Speed and quality of safety analysis, interpretation and presentation Compliance with internal and external regulations and procedures Maintaining safety, consistency and quality

Work Experience

Operations management and execution Project Management Intra-company collaboration Functional extension People management issues Crisis management

Skills

Clinical Research Process safety Regulatory compliance Functional teams Safety science Literature review Medical records Clinicians Language English

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Medical Safety Expert