Medical Safety Lead/sr
vor 3 Wochen
**Sourcing Statement**
766 million. That’s how many lives our products touch. 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?
**Senior Medical Safety Lead**
As our MSL, you will be in close collaboration with the Global Program Safety Lead (GPSL) providing robust safety evaluation expertise and medical innovation in order to improve patients’ lives and impact on overall Novartis results.
As a member of the Medical Safety organization, you prioritize the safety of patients, ensure optimal patient safety for assigned compounds and share responsibility for the integration, analysis, and evaluation of internal and external safety information through product lifecycle management. You may also deputize partial or full responsibilities of a GPSL.
**Your Responsibilities Include, but are not limited to**:
- Monitor the clinical safety of projects/products including activities such as literature review, evaluation of
individual cases or signal detection, and respond to safety-related questions appropriately. You may deputize for the GPSL (in agreement with the project’s GPSL) or function as a GPSL for products to which no GPSL are assigned.
- Perform medical assessment and related activities for single cases whenever required, including collecting
additional follow-up information as necessary, medical evaluation of quality defects, review of line listings
of single cases, literature review and preparation of investigator notifications and periodic medical
assessments for ethics committees. Of note: medical review of single case reports may need to be
performed by Senior Medical Safety Leads as required according to business needs.
- Identify safety signals based on the review of solicited or unsolicited single cases. Perform signal detection, monitoring and evaluation of all safety signals based on single cases and aggregate data using proper signal detection tools.
- Provide inputs into responses to inquiries from regulatory authorities or health care professionals on
safety issues. Prepare safety data for Health Authority review boards. Provide input to responses for legal queries and Country Organization requests involving safety issues.
- Provide pharmacovigilance inputs to initial development and subsequent updates of core data sheet (CDS) and its related documents. May review and author submission documents (e.g. summary of clinical safety, clinical overview).
- Play a significant role in the development and maintenance of Safety Profiling Plans (SPP) and Risk
Management Plans (RMP) including the coordination with other line functions for associated activities such as updates, and the ongoing tracking of commitments and effectiveness measures.
- Provide guidance as appropriate to Clinical/PV Safety Operations for the coding and causality/expectedness assessment of adverse event reports
**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'll bring to the role**:
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required.
- Medical degree with specialization preferred. Medical degree is essential for associates performing medical review of single case reports whenever business needs require this activity.
**Experience/Professional requirement**:
- Relevant experience (e.g., clinical, postdoctoral) after graduation
- At least 6 years in drug development in a major pharmaceutical company, including 4 years in patient safety at an operational or medical position (or
equivalent experience) is desirable.
- Experience in drug development, clinical trial methodology, regulatory requirements,
scientific methodology, statistics and writing of publications.
- 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
- Experience with (safety or others) issue management
**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
**Alternative Country 3**
India
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
-
Medical Safety Director
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitAbout UsWe are a global leader in generic and biosimilar medicines, committed to improving access to healthcare for patients worldwide. We are seeking a highly experienced Medical Safety Director to join our team.Key Responsibilities:Medical Safety Leadership: Lead the medical safety function, ensuring compliance with regulatory requirements and good...
-
Global Program Safety Lead/sr
vor 3 Wochen
Basel, Schweiz Novartis Vollzeit**Sourcing Statement** *Roles will be filled at level commensurate with experience and in the following locations: United States, Europe (Switzerland, Spain) and United Kingdom* Therapeutic Areas include, but are not limited to: Immunology, Hepatology and Dermatology; Neuroscience; Ophthalmology; Oncology; BioPharma & Generics 769 million. That’s how...
-
Medical Safety Lead
vor 2 Wochen
Basel, Schweiz Novartis VollzeitMore than 52 different medical diseases! Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative medicines. - As our Medical Safety Lead within...
-
Sr. Medical Director
vor 4 Wochen
Basel, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Sr. Medical Director - Apraglutide, Basel-StadtClient:Ironwood PharmaceuticalsLocation:Basel, Switzerland (remote) or Boston, USA (remote)Job Reference:b6a54c55ee7bJob Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:VectivBio is a global, clinical-stage biotechnology company focused on the discovery,...
-
Head Medical Safety
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Description SummaryDesigns and develops safety surveillance strategy for products and approval. Responsible for the company's 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...
-
Global Program Safety Lead
vor 1 Woche
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitGlobal Program Safety Lead – RLTPrimary Location: Basel, Switzerland (80-100%)Alternate Location: Barcelona, SpainWorking model: All locations have a hybrid working model (which requires 12 days per month in the office)Note: Novartis is not able to offer relocation support for this role. Please only apply if one of these locations is accessible for...
-
Global Program Safety Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitGlobal Program Safety Lead – RLTPrimary Location: Basel, Switzerland (80-100%)Alternate Location: Barcelona, SpainWorking model: All locations have a hybrid working model (which requires 12 days per month in the office)Note: Novartis is not able to offer relocation support for this role. Please only apply if one of these locations is accessible for...
-
Global Program Safety Lead
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitGlobal Program Safety Lead – RLTPrimary Location: Basel, Switzerland (80-100%)Alternate Location: Barcelona, SpainWorking model: All locations have a hybrid working model (which requires 12 days per month in the office)Note: Novartis is not able to offer relocation support for this role. Please only apply if one of these locations is accessible for...
-
Oncology Medical Director
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitThe Global Safety Lead plays a key role in ensuring the safety of patients and customers by providing expert safety input to the clinical development program for assigned projects/products. This role is part of our Radioligand Therapy team and requires a strong expertise in drug development, clinical trial methodology, regulatory requirements, scientific...
-
Global Safety Lead Specialist
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAs a Global Safety Lead at Novartis Farmacéutica, you will excel as a scientific safety leader within the Oncology Medical Safety organization. This role is part of our Radioligand Therapy team and requires a strong expertise in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing of...
-
Clinical Development Medical Director
vor 16 Stunden
Basel, Schweiz Novartis Vollzeit2 billion people, half a billion are children. That’s the burden of the world’s infectious diseases on the underserved and poorest populations in Africa, Asia and Latin America, and many of these diseases are without vaccine or curative treatment. In Global Health, we focus our expertise on delivering life-enhancing medicines and improving access to...
-
Associate Safety Medical Director
vor 2 Wochen
Basel, Schweiz BioTalent VollzeitBioTalent is collaborating with an Innovative Swiss based BioTech company in the rare disease field. We are looking to appoint an Associate Medical Director of Drug Safety in a full time capacity. This is a rare opportunity for an experienced individual to join a forward thinking and expanding company. **Offer**: - Permanent, full time position -...
-
(Sr) Safety Scientist/associate Safety Director
vor 2 Wochen
Basel, Schweiz BioTalent Vollzeit**You will be Responsible For Activities including**: Aggregate case reporting (ICSR), aggregate report (DSUR, PSUR), signal detection/management, safety strategy, input to clinical development strategy (from safety perspective), Risk management (CCDS, IB, RMP, IND/NDA, MAA), support, presentations, publications, vendor relations **You will bring the...
-
Basel, Schweiz Novartis Vollzeit12,000! This is the number of global drug development associates Novartis has worldwide. We are courageous in developing transformational medicines to address the unmet needs of patients. As an Associate/Clinical Development Medical Director (a/CDMD or CDMD**), you will join the ophthalmology team, who are committed to helping patients. You will be...
-
Clinical Development Medical Director, Car-t 80-100%
vor 2 Wochen
Basel, Schweiz Novartis Vollzeit22! the number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology. And while we’re proud of that, 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? -...
-
Safety Director
vor 2 Wochen
Basel, Schweiz BioTalent Vollzeit**You will be Responsible For**: - Expertise in clinical interpretation of safety assessments and device safety reports. - High level response to regulatory authority requests - Develop safety materials and reports - Safety assessment for signals or issues - Risk management, Investigator brochures etc **You will bring the following**: - Health care...
-
Global Head of Medical Safety Operations
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitAbout the RoleThe Global Head of Medical Safety Operations will be responsible for leading the development and implementation of global medical safety operations strategies, ensuring compliance with regulatory requirements and good clinical practice.Key Responsibilities:Global Medical Safety Operations Strategy Development: Develop and implement global...
-
Clinical Safety and Risk Management Leader
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitThe Clinical Safety and Risk Management Leader at Novartis Farmacéutica plays a critical role in ensuring the safety of patients and customers by overseeing overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information. This role is part of our Radioligand Therapy team and requires a strong expertise in...
-
Medical Development Lead
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Vectura Fertin Pharma VollzeitAbout the Role:">As a Senior Clinical Development Scientist, you will contribute to our lead programs in Inhaled Therapeutics. This role involves providing clinical research support and expert scientific input to assigned clinical studies and programs.">Main Responsibilities:">Develop clinical trial/program level documents including clinical trial protocols,...
-
Sr Medical Manager Digestive Health
vor 3 Wochen
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
