Associate Director, Quantitively Safety & MedDRA
- Hyderabad, India
- Closing date
- Mar 27, 2023
- Position Type
- Full Time
- Job Type
- Organization Type
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:
• Define and oversee long term strategy to ensure that Sandoz maintains its world class leading position in automated signal detection and evaluation.
• Lead and manage a team of external service providers who are accountable for detecting and analyzing technical signals from post- marketing surveillance in the signal management tool for all Sandoz products, Sandoz group companies or Sandoz partners (for which an agreement is in place) where Sandoz is the global safety database holder.
• Oversee and ensure maintenance of all Sandoz MedDRA Queries which are used by the entire Sandoz organization.
• Develop new approaches (including policy, methodology, process improvements) for signal detection in Safety Signal databases.
• Core member of the Safety management team to provide expert input into Safety Evaluations presented at the Safety Management Team.
• Drive the development and implementation of efficient workflow processes for the Signal Management Team, the update of Business Guidance Documents and SOPs accordingly.
• Bring strong scientific and medical safety leadership to oversee all signal detection activities that are performed by the Safety Signal Management team using internal and external databases, ensuring industry best practices and alignment with regulatory guidance.
• Ensure that all new relevant medical safety signals originating from signal review or analyses from external Health Authority databases are adequately communicated to the respective Safety Lead for further escalation to the SMT.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Masters in relevant field or Medical Degree (MBBS or MD) required. Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) preferred.
• Relevant experience (e.g., clinical, postdoctoral) after graduation. At least 4 years in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, postmarketing in a major pharmaceutical company, including 2 years in signal detection and management (or equivalent experience) is desirable.
• Proven ability to analyze, interpret, discuss, and present safety information both in writing and orally.
• Experience in preparing or contributing to preparation of clinical safety. assessments and regulatory reports involving safety information
• Experience in MedDRA and post marketing safety signal detection. Experience with (safety or others) issue management and decision making on safety topics.
• Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, post marketing, signal detection and writing of publications desirable
• Requires the ability to develop and maintain effective working relationships with subordinates, superiors and peers; Excellent written and verbal communication skills. Experience with PV audits and inspections and writing and implementation of CAPA
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!
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
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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