Executive Director, Global Medical Safety
vor 1 Monat
**Executive Director, Global Medical Safety**
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
**The Opportunity**
**Responsibilities**
- Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
- Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
- Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
- Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
- Responsible for responding to and resolving safety questions from regulatory authorities.
- Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
- Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
- Support regulatory agency audits and inspections, and corrective action plans
- Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations
**Minimum Qualifications**:
- Advanced medical degree (e.g., MD, MBBS, DO) required
- 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post
- marketing environments.
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
- Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics
- Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
LI-SC1
-
Global Medical/scientific Director
vor 1 Monat
Zurich, Schweiz Novo Nordisk VollzeitAre you looking for an exciting and leading role in supporting Novo Nordisk Rare Disease by extending our commitment and leadership in rare endocrine disorders? Are you looking to work in a fast-paced dynamic and international environment where you can drive change and improve patient care on a larger scale? If yes, then we have the perfect opportunity for...
-
Global Business Office Director
vor 1 Monat
Zurich, Schweiz Celestica VollzeitReq ID: 117448 Remote Position: Yes Region: Europe Country: Switzerland State/Province: Zurich City: Zurich **Summary**: The Global Business Office Director is responsible to manage a team of one or more global program managers on a particular customer or customer group or division. The Director has the responsibility to ensure that all operational concerns...
-
Global Medical Lead Dengue, Global Medical Affairs
vor 2 Wochen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. For our Swiss HQ in Zurich, we are looking for a **Global Medical Lead Dengue (M/F/d), Global Medical...
-
Medical Information Manager
vor 1 Tag
Zurich, Schweiz Takeda Pharmaceutical VollzeitJob Description **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. **For our Swiss HQ in Zurich, we are looking for a Medical Information Manager /...
-
Executive Assistant
Vor 7 Tagen
Zurich, Schweiz Corza Medical Vollzeit**Location of Work** - Zurich, Switzerland **Employment Type** - Full Time Employee - At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves. - Our product family is the result of years...
-
Executive Office Project Director
vor 2 Monaten
Zurich, Schweiz Novo Nordisk VollzeitExecutive Office Project Director **Category**:Project Management & Agile**Location**:Zurich, Switzerland Zurich, CH- Are you ready for a new challenge that will make a true impact?- Are you ready to drive our cross functional strategic projects? Then we are looking for you!- Become our new Executive Office Project Director and shape the future of...
-
Medical Affairs Director
vor 1 Monat
Zurich, Schweiz Novo Nordisk VollzeitMedical Affairs Director (100%) **Category**:Medical Affairs**Location**:Zurich, Switzerland Zurich, CH- Are you passionate about shaping an affiliate medical strategy, ensuring compliance, and fostering team growth? Do you want to make a lasting impact? Are you ready to lead the way within Medical Affairs?- If so, then seize the opportunity and become the...
-
Account Executive
vor 1 Woche
Zurich, Schweiz 3M VollzeitJob Description: Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies...
-
Director, Global Pricing
vor 1 Monat
Zurich, Schweiz MSD VollzeitOur Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. The Director, Global Pricing within the Global Market Access...
-
Director, Global Pricing
vor 1 Woche
Zurich, Schweiz MSD VollzeitOur Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. The Director, Global Pricing within the Global Market Access...
-
Medical Information Manager
vor 2 Wochen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. For our Swiss HQ in Zurich, we are looking for a **Medical Information Manager / Medical Information...
-
Medical Information Manager
Vor 2 Tagen
Zurich, Schweiz Swisslinx VollzeitOn behalf of our client, an international healthcare company based in Switzerland, Swisslinx is looking for a Medical Information Manager. This is a contract for 12 months initially and in this role you will be responsible for the management of complex inquiries for EMEA across company's global product portfolio. - Start date: As soon as possible - Duration:...
-
Medical Information Manager, Emea
vor 1 Monat
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** **_ OBJECTIVES/PURPOSE_** - Management of medical information content in alignment with the product...
-
Country Medical Director
vor 2 Wochen
Zurich, Schweiz Pfizer VollzeitCountry Medical Director (M/F/d) This is what you can look forward to: Role responsibilities - Directly leads all medical affairs functions, ensuring operational excellence for customer-facing medical, evidence generation, medical enablement functions, etc. - Partners with the Country Manager to ensure alignment with country strategies and represents all...
-
Medical Information Operations Manager
vor 2 Monaten
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**Job Overview**: - Support and lead operational development, implementation and maintenance of Global Medical Information (GMI) processes and related procedural and guidance documents in EMEA region - Ensure adherence and compliance to GMI processes in EMEA region - Support the GMI participation in internal or 3rd party audits impacting EMEA Medical...
-
Gmi Medical Information Lead
Vor 6 Tagen
Zurich, Schweiz Swisslinx VollzeitOn behalf of our client, an international healthcare company based in Switzerland, Swisslinx is looking for a GMI Medical Information Lead. This is a contract for 12 months initially and in this role you will be responsible for the management of complex inquiries for EMEA across company's global product portfolio. - Start date: As soon as possible -...
-
Medical Information Manager
Vor 5 Tagen
Zurich, Schweiz Hobson Prior Vollzeit**Salary**: Negotiable**Job type**: Interim/Contract **Location**: Zürich, Switzerland **Function**: Medical, Medical Communication **Posted**:15/03/2024 **Ref**: BBBH24897 - Hi I'm Terrah-Leigh , I manage this role Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - Manage...
-
Executive Brand
vor 1 Monat
Zurich, Schweiz Wirz Communications AG VollzeitDu bist engagiert und kommunikativ, denkst gleichermassen strategisch wie kreativ und heckst gerne aussergewöhnliche Pläne aus? Du willst Marken weiterbringen, neue Standards setzen und 08/15 Ideen sind dir ein Graus? Zudem behältst du auch in herausfordernden Situationen stets den Überblick und lässt dich von nichts aus der Ruhe bringen? Dann ist...
-
Global Patient Advocacy Director
vor 1 Monat
Zurich, Schweiz Novo Nordisk VollzeitGlobal Patient Advocacy Director **Category**:Corporate Affairs**Location**:Zurich, Switzerland Zurich, CH- Are you ready to establish meaningful relationships with patients, leveraging their insights to create value for the industry? Can you confidently represent our organization at congresses and engage in various communication platforms such as...
-
Associate Director
vor 1 Monat
Zurich, Schweiz Takeda Pharmaceutical VollzeitAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an **Associate Director/Director Global Regulatory Lead - Rare Disease** in our Zurich office. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES**: - Defines, develops and leads global strategies...