Medical Safety Expert

2 months ago

Hyderabad, India Novartis Full time

2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role.
- Your responsibilities include, but are not limited to:
- Provide support according to the needs for delivery activities, i.e. SUSAR ICSR medical review when needed, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Assist the GPSL/MSL in monitoring the safety profile of products including with activities such as literature review, medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects or signal detection. Medical review of single case reports will be performed by associates possessing medical degree.
- Perform Literature review for PSUR inclusion and assessment of literature for signals. Provide support for the preparation of ad hoc Health Authority queries, provide input into responses to inquiries from health care professionals on safety issues
- Together with the Safety Leads, co-author the PSUR sections as required, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. Perform follow up activities on Health Authority Assessment Reports.
- Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), support maintenance and management of local deviations to Global CDS (SMPC, USPI, Japanese PI)
- Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).
- Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs).
- Provide safety input (Addendum to Clinical Overview) for license renewal documents, Co-author medical assessment of product quality issues. Contribute to the development and update of RMPs in collaboration with MSL/GPSL, coordination with other functions

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required. Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
- For life sciences graduate - 3 years in patient safety at an operational or medical position. May be a first job in the pharmaceutical industry for an MD or with 2 or more years of clinical experience after 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 communication skills, and the ability to operate effectively in an international environment
- Excellent understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. Strong technical understanding of Biomedical/Biostatics concepts and problem-solving skills
- Ability to work independently, under strict timelines, demonstrating initiative and flexibility through effective innovative leadership ability

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

**Division**
- Novartis Tec

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