Medical Safety Lead

325418BR
Aug 23, 2021
India

Job Description

Your responsibilities include, but are not limited to:

• Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations.
• Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.
• Monitors the clinical safety of projects /products including activities such as literature review, evaluation of individual cases or signal detection, and responds to safety related questions appropriately.
• Performs medical assessment and related activities for cases whenever required, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, review of line listings of single cases, and preparation of investigator notifications and periodic medical assessments for ethics committees.
• Identifies safety signals based on the review of solicited or unsolicited single cases. Performs signal detection, monitoring and evaluation of all safety signals. Provides inputs into responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Prepares safety data for Health Authority review boards. Provides inputs to responses for legal queries and Country Organization requests involving safety issues. Provides expert evaluation on the clinical context of adverse event reports, assessment of the medical conditions, and the implications on Novartis products.
• Collaborates productively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments. Contributes to the development of departmental goals and objectives.

Minimum Requirements

• Working experience within the pharmaceutical industry Experience above 3years medicinal products for human use Clinical Research Phases Clinical Trial Design, Data Review & Reporting Benefit/Risk Evaluation/Epidemiology M.B.B.S/M.D/PhD
• Lead the safety profile assessment for a particular product/project - End to end safety surveillance of a product/project
• Lead to maximize Global health products in market and/or in pipeline
• People Leadership Operations Management and Execution Collaborating across boundaries People Challenges Critical Negotiations English NA

WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
CMO & PATIENT SAFETY GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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325418BR

Medical Safety Lead

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