Medical Safety Writer- Aggregate Reports
2 weeks ago
2600+ Aggregate Reports annually Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.
- Your responsibilities include, but are not limited to:
- Lead preparation of global periodic safety reports for newly launched products.
- Lead coordination with GLFs to ensure information received, analyzed, and incorporated into ARs as per the regulatory requirements.
- Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards
- Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
- Support in the development of safety document templates and Standard Operating; Procedures pertaining safety aggregate reports. Contribute to global projects focusing on process & quality improvement initiatives.
- Train and mentor new CMO&PS associates and associates from other line functions on medical safety writing & periodic reporting matters. Support Head, Safety Report.
**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**
- Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent Degree
- 4 to 8 years’ experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years’ experience in in safety/medical/scientific/regulatory writing
- Preferably, at least 2 years of experience in safety writing; Sound expertise in data analysis and presentation
- Strong project management and communication skills. Ability to lead global and cross-functional work groups
- Excellent understanding of drug development process, GCP and medical terminology. Ability to mentor and guide
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**
- Global Drug Development
**Business Unit**
- CMO & PATIENT SAFETY GDD
**Country**
- India
**Work Location**
- Hyderabad, AP
**Company/Legal Entity**
- Nov Hltcr Shared Services Ind
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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