Drug Safety Physician
vor 3 Wochen
We have an exciting opportunity for a Drug Safety Physician (m/w/d) in Switzerland
Tasks
- You are responsible for safety aspects of marketed products, including reviewing post-marketing AE reports, signal detection, risk management, and risk minimization.
- Lead the Safety Management Team, ensuring integration and interpretation of safety information.
- Coordinate and ensure quality presentations by the SMT at Drug Safety Committee (DSC).
- Participate in Clinical Project and Life Cycle Team meetings.
- Responsible for overall signal detection, monitoring, and preparation of safety reports (DSUR, PSUR/PBRER).
- Contributes to key regulatory safety documents including RSI in the IB and RMP/REMS.
- Review and triage AE reports, ensuring proper assessment and documentation.
- Handle safety inquiries from regulatory authorities and healthcare professionals.
- Coordinate involvement of external experts and support licensing agreements.
- Assist in managing regulatory inspections and collaborate with Quality Management on product complaints associated with AE.
**Requirements**:
- You hold a Doctor of Medicine degree with at least 5 years of experience in global drug safety in the pharmaceutical or biotechnology industry.
- Your knowledge spans medicinal products, diseases, safety surveillance, and pharmacovigilance, derived from both didactic and clinical backgrounds.
- You excel in post-marketing adverse event reporting systems, product safety monitoring, and the preparation of regulatory safety documents.
- Proficient in global safety regulations, GCP, GVP, and pharmacovigilance compliance, you ensure adherence to industry standards.
- Your familiarity with key safety documents like DSUR, PBRER, RMP, and CCDS enhances your effectiveness in safety management.
- You're skilled in safety signal identification and implementing risk minimization strategies.
- Your exceptional medical writing and presentation abilities facilitate clear communication within cross-functional teams.
- Your organizational prowess ensures timely project delivery, supported by your experience with the Argus Safety database.
Thank you for considering this opportunity. I look forward to connecting with you.
-
Clinical Safety Physician
vor 1 Monat
Basel, Schweiz Manpower VollzeitDo you want to join VecturaFertinPharma (Philip Morris)? We're looking for a: **Your mission** Duration : open-ended contract through Manpower Location : Basel or Neuchâtel or Remote In this role as Clinical Safety Physician you are responsible for implementing and overseeing all areas of safety monitoring and reporting for clinical trials for Vectura...
-
Drug Safety Trainee
vor 1 Monat
Basel, Schweiz OM Pharma Ltd. VollzeitLocation: Villars-sur-Glâne, Fribourg, CH- Division: - Division: Drug Safety- Job Type: TraineeshipOM Pharma has positioned itself as a local player in supporting students and young graduates in their first professional experiences. In this context, we are pleased to offer a 12 months paid internship, starting as soon as possible, as a **Drug Safety...
-
Director Drug Safety
Vor 5 Tagen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Director Drug Safety
Vor 5 Tagen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Clinical Project Physician
vor 1 Monat
Basel, Schweiz CTC Resourcing Solutions Vollzeit**_The Life Science Career Network_** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a for a** Clinical Project Physician for a 12 month contract role based in the Basel area. **The CPP...
-
Director Drug Safety
Vor 4 Tagen
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary platform that...
-
Senior Director Drug Safety
vor 15 Stunden
Basel, Schweiz Batterman Consulting Basel AG VollzeitOur client Skyhawk is a clinical-stage biotechnology company developing novel small molecules designed to modulate RNA processing of disease targets, including those traditionally thought to be “undruggable,” and yield therapies for some of the world’s most intractable diseases. They have built a sophisticated, integrated proprietary...
-
Global Product Safety Science Lead
Vor 2 Tagen
Basel, Schweiz Hobson Prior Vollzeit**Salary**: CHF170000 - CHF190000 per annum**Job type**: Permanent **Location**: Basel, Switzerland **Function**: PVG & Drug Safety, Global Drug Safety **Posted**:28/06/2023 **Ref**: BBBH22928 - Hi I'm Nyvine , I manage this role Hobson Prior are seeking for a Global Product Safety Science Lead to join a brilliant biopharmaceutical organisation on a...
-
Global Program Safety Lead
vor 1 Monat
Basel, Schweiz Novartis Vollzeit391327BR **Global Program Safety Lead - Immunology**: Switzerland **About the role** The GPSL ensures optimal patient safety and leads the integration, analysis and interpretation of internal and external safety information from all sources through lifecycle management. This position reports to the Head Patient Safety Immunology. **Key...
-
Global Product Safety Science Lead
Vor 2 Tagen
Basel, Schweiz Sobi VollzeitRole & Function The Global Product Safety Science Lead is a key role within Global Pharmacovigilance (PV) and Patient Safety. You will be leading the safety surveillance activities for assigned marketed Sobi products and for products under development. As part of our PV team, you will be working collaboratively with other PV functions to ensure that safety...
-
Global Product Safety Scientist
Vor 2 Tagen
Basel, Schweiz Sobi Vollzeit**Company Description**: - Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic...
-
Head of Technology, Patent Safety
vor 1 Monat
Basel, Schweiz Sandoz Vollzeit2023 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...
-
Cmc Lead Drug Substances
vor 4 Wochen
Basel, Schweiz Hobson Prior Vollzeit**Salary**: CHF150000 - CHF165000 per annum**Job type**: Permanent **Location**: Basel, Switzerland **Function**: Technical Operations, Quality Control, Chemist **Posted**:05/05/2023 **Ref**: BBBH22209 - Hi I'm Christopher , I manage this role Hobson Prior are seeking for a CMC Lead Drug Substances to join a fantastic biotech establishment on a...
-
Clinical Scientist
vor 4 Wochen
Basel, Schweiz Hobson Prior VollzeitHobson Prior are seeking for a Clinical Scientist to join a fantastic pharma corporation on a contract basis located in Basel. Our client is focused on offering access to novel solutions to change the lives of those suffering from rare illnesses. Please note that to be considered for this role you must have the right to work in this location. **Key...
-
Cmc Lead Drug Substances
Vor 2 Tagen
Basel, Schweiz Sobi Vollzeit**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **CMC Lead Drug...
-
Pharmacovigilance Manager
vor 1 Monat
Basel, Schweiz CSL Behring VollzeitAt this position, you are part of the Regulatory Affairs and Pharmacovigilance Team within the Medical Department of the Swiss affiliate at CSL Vifor (no direct reports). You are the main responsible person for independently processing drug safety reports for our products. You perform your tasks in collaboration with other colleagues of the same team as well...
-
Drug Substance Cmc Lead
Vor 2 Tagen
Basel, Schweiz Sobi Vollzeit**Drug Substance CMC Lead** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic...
-
International Pv Business Process Leader
vor 1 Monat
Basel, Schweiz CTC Resourcing Solutions Vollzeit**_The Life Science Career Network_** **International PV Business Process Leader** Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly...
-
Head of Clinical Development, Recordati Rare
Vor 2 Tagen
Basel, Schweiz Recordati Group VollzeitThe purpose of the role is to lead the Clinical Development Team and work with all centrally managed groups, including Clinical Operations, Regulatory, Safety, Preclinical and CMC teams, to efficiently develop new drugs and manage Life Cycle programs of marketed drugs, in line with the agreed strategy for the Rare Diseases business and in compliance with all...
-
Scientist in Proteomics
vor 1 Monat
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client, a pioneer in Drug Discovery and Development and a leader in Personalized Healthcare, stands at the forefront of innovation. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they operate across a wide spectrum of drug discovery and therapeutic areas, earning global...