About the role
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!
To support the Medical Safety team in their daily activities including preparation (from technical perspective) of documents for further processing, review and expediting. Ensure technical compliance of documents with technical guidelines. To support management of Medical Safety operational processes within the Global Medical Safety team in ensuring compliance with Sandoz global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Sandoz group marketed and investigational products.
Your Key Responsibilities:
-Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Archiving all safety documentation as per respective policies, guidance, and procedures. Updating the Medical Safety sharepoint, uploading of documents, tracking and planning list updates
-Verification and update of respective PS archiving system (incl. review, update, management). Monitoring of the compliance
-Support in organizing response to queries from Countries and regions and other functions outside medical safety. Support in developing, updating, and implementing global procedures to ensure compliance.
-Management and maintenance of relevant Global PS databases/sharepoint. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to HA, development and implementation of corrective action(s) as needed.
-Preparing metrics as required and agreed with the manager. Support the Group Head, Medical Safety Operations/Medical Safety Group Lead/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA in day to day operations as per assigned responsibilities. Support Literature review for PSUR inclusion and assessment of literature for signals
-Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA. Support in preparation of responses to internal safety requests and contribute to responses to external safety queries
-Writing of meeting minutes. Provides support as needed for regulatory authority inspections and internal/external audits. Assist in Root cause analysis (RCA) and Corrective and Preventive Actions (CAPA) as appropriate. Preparing presentations with support from the safety lead as applicable for various safety teams as well as leadership forums.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
1. Timeliness and quality of deliverables, and presentations (attention to details, thoroughness, medical sound judgment, written content accuracy and completeness)
2. Compliance with internal and external regulations and procedures.
3. Ability to work effectively within a matrix organization
4. High level of independence
5. Results of audits/inspections
6. Timely introduction of the respective data into the system/tracking tool
7. Timely and quality of prepared documentation, training materialsWhy Sandoz? 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this? 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!
NON-NVS TSA SANDOZ GLOBAL DEVELOPMENT
Sdz Pvt Ind
Research & Development
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