Director Quantitative Safety Scientist

vor 2 Wochen

Basel, Schweiz Novartis Vollzeit

1 in 10,000 is the frequency of a rare safety event
- The science of detecting, quantifying and communicating adverse drug reactions as well as designing measurable risk minimization activities - this is quantitative safety science. Providing patients with more benefits than risks is Novartis’ top priority.
- As Director Quantitative Safety Scientist you will shape the quantitative safety strategy for multiple programs across multiple indications during the whole life cycle. You will set innovative scientific and functional standards for excellence in signal detection, safety evaluation and benefit-risk assessment to inform internal and external evidence-based decision-making.**Your responsibilities include, but are not limited to**:

- Establishing the quantitative safety science strategy for assigned programs during the full life cycle, including early and full development, pre-, peri
- and post
- regulatory submissions
- Expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, influence and implement publication strategy, quantitative decision making) for complex, critical studies across programs/indications
- Leading collaborations and effective partnerships with medical safety, epidemiology, clinical, regulatory and other quantitative scientists to ensure quantitative decision-making based on data from different sources in a pro-active manner
- Proposing and implementing modern and innovative statistical methods to support safety signal detection, safety risk and benefit-risk assessment. Promoting their use and acceptance within and outside of the organization through presentations, publications and scientific collaborations.
- Identifying and leading cross-functional scientific improvement and change initiatives providing strategic, technical, operational, and scientific solutions to the organization
- Representing Quantitative Safety & Epidemiology at internal and external decision boards
- Mentoring others in developing strategic quantitative frameworks

**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**

**What you will bring to the role**:

- University degree in statistics or mathematics or related area (PhD preferred)
- 10+ years (or 8+ years for PhD) of relevant experience in positions with growing responsibility in the Pharmaceutical Industry
- Expert knowledge and substantial experience of statistical methods applied to drug development and post-marketing safety and benefit-risk assessments with impact on company and/or health authority decisions. Hands-on experience in interactions with regulatory agencies.
- Demonstrated experience in developing and evaluating modern quantitative safety methodologies. Computing ability and experience with different data sources.
- Scientific curiosity combined with strong communication skills bridging scientific and business needs over different expertise areas
- Proven successful experience in leading global scientific improvement/ change initiatives. Natural modern leadership style building partnerships and collaborative environments

**Why consider Novartis?**

766 million. That’s how many lives our products touched in 2021. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at Novartis**Division**
- Global Drug Development**Business Unit**
- CMO & PATIENT SAFETY GDD**Country**
- Switzerland**Work Location**
- Basel**Company/Legal Entity**
- Novartis Pharma AG**Alternative Country 1**
- USA**Alternative Country 2**
- Spain**Functional Area**
- Research & Development**Job Type**
- Full Time**Employment Type**
- Regular**Shift Work**
- No**Early Talent**
- No

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