Senior Medical Safety Lead
Patient Safety & Pharmacovigilance
Location
Andhra Pradesh | India
Job description
About the Role
Job Purpose
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.
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• 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.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable)
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
WHAT YOU’LL BRING TO THE ROLE:
• Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required. Medical degree is essential for associates performing medical review of single case reports. Good fluency in English. Knowledge of other languages desirable.
• 3+ years of PV or Clinical Drug Development experience post MBBS.
• Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries.
• Excellent understanding of clinical trial methodology, ICH GCP , GVP guidelines and medical terminology
• Attention to detail and quality focused.
• Strong organizational and project management skills
• Strong negotiation and communication skills, and the ability to operate effectively in an international environment.
• Excellent understanding of physiology, pharmacology, clinical study objectives, and the drug development process
• Strong technical understanding of Biomedical/Biostatics concepts and problem-solving skills.
• Good presentation skills and strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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