Medical Safety Expert- Pharmacovigilance (MRQC) - #1231543
Date: Jun 23, 2022
Contract type: Full time
Work schedule: Full day
23! You will be part of this 23 member team of next generation Safety Leaders generating scientific (safety related) inputs for numerous compounds spread across nine exciting Therapeutic Areas
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.
- Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. Perform literature review. Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests.
- Perform follow up activities on Health Authority Assessment Reports. Assist in providing safety input to Regulatory Affairs and clinical documents. Support maintenance and management of local deviations
- Assist in evaluating and writing other safety deliverables as assigned Provide support as needed for new indication submission (regulatory document safety input). Prepare responses to internal safety requests and contribution to responses to external safety queries.
- Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues.
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.
- MBBS or MD required, Medical degree is essential. Good knowledge/fluency in English. Knowledge of other languages desirable. 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
- Good presentation skills. Strong computer skills including, but not limited to, creation of spreadsheets, templates, presentations and working with safety databases/applications.
- Ability to work independently, under pressure, demonstrating initiatives.
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!
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
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
Nov Hltcr Shared Services Ind
Research & Development