Search Results: 32 vacancies
...Development (medical ICSR discussion and follow-up, as well as safety surveillance). The role supports regulatory compliance with pharmacovigilance regulations, safety signal detection/management, and contributes to the overall benefit-risk management of Exelixis products....
Suggested
Holiday work
Contract work
Local area
Flexible hours
...Vice President, Clinical Safety & Pharmacovigilance
About the Company
Prominent biotechnology (BioTech) organization accelerating evidence-based mental health solutions
Industry
Biotechnology
Type
Privately Held
About the Role
The Vice President...
Suggested
...Senior Vice President, Medical, Regulatory & Pharmacovigilance
About the Company
Pioneering healthcare company
Industry
Hospital & Health Care
Type
Privately Held
About the Role
The Company is seeking a Senior Vice President for Medical, Regulatory...
Suggested
...Location: South San Francisco, CA; Agoura Hills, CA; Remote candidates will be considered
Job Title: Senior Medical Director, Pharmacovigilance
Reports To: Executive Director, Safety and Pharmacovigilance
Function: Pharmacovigilance
Job Type: Full time...
Suggested
Full time
Remote job
...Assess emerging safety data, ensure appropriate risk communication, and development of risk management/minimization strategies
Pharmacovigilance strategy and implementation
Aggregate safety reports, including DSURs, Health Authority SAE reporting and other safety...
Suggested
Holiday work
Internship
Local area
...experience of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP).
* Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set...
Suggested
Full time
Contract work
Flexible hours
...and with business partners from IT and their vendors.
Essential Functions/Responsibilities
Excellent working knowledge on pharmacovigilance and drug safety regulations (ICH, GxP)
Work to streamline and optimize business processes based on industry best practices....
Suggested
Remote job
Local area
Flexible hours
...Research Organization
Rare diseases
Phase I-V
Drug Development
Pharmaceuticals
Biotechnology
Clinical Trials
pharmacovigilance
covid 19
clinical safety
Medical Information
and Allergy
About the Role
The Vice President of Biometrics at...
Suggested
Contract work
...and professional member of relevant teams. Leads signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions.
Essential Functions:
Lead the monitoring...
Suggested
Local area
...ISR submission and execution process and study follow-up as agreed upon with home office medical and GDO
+ Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any...
Suggested
Holiday work
Temporary work
Summer work
Local area
Remote job
Home office
Shift work
...programs.
* Provide clinical safety oversight/guidance as designated by the Medical Monitoring Plan to CRO, Clinical Operations, Pharmacovigilance and study sites as needed.
* Work closely with internal team and CRO in execution of trials and provide ongoing guidance to...
Suggested
Temporary work
Remote job
...requirements. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Qualifications...
Suggested
...Administration
Known Requirements
Bachelor's degree in medicine or related field required
A minimum of 5 years' experience in pharmacovigilance required
Superior leader with solid expertise in medical surveillance issues required
Exceptional work ethic and strong...
Suggested
...investigator brochures, general investigational plans, annual safety reports, regulatory briefing packages, INDs, and NDAs
* Oversee pharmacovigilance activities across pipeline
* Over time, build, mentor, and manage a clinical team of medical directors to support Mazes...
Suggested
...assessment) for early oncology products with a proactive approach to clinical safety, and will be interpreting regulations related to pharmacovigilance to support all patient safety activities.
Responsibilities:
+ Understanding and application of the pharmacology,...
Suggested
Holiday work
Temporary work
Local area
...Requirements:
~ Health Care Professional degree (e.g. RN/BSN/MSN, NP, Rph/B Pharam/Pharm D, or MD) required
~2+ years of clinical / Pharmacovigilance experience depending on education level
~ Medical writing experience
Additional Details:
Schedule: Monday-Friday...
Contract work
Remote job
Monday to Friday
...with our long-term business objectives, collaborating closely with departments such as Finance, HR, Legal, Quality, Clinical, Pharmacovigilance, Regulatory, Research Infrastructure and Technical Operations. Join us in creating a tech landscape that propels our company to...
Holiday work
...phase 2 and 3 clinical trials, collaborating closely with cross-functional teams, including clinical operations, regulatory, pharmacovigilance, and other relevant departments.
Patient Safety Oversight: Monitor the safety of subjects participating in clinical trials,...
Temporary work
Remote job
Flexible hours
...in building the Alumis Quality organization strategy and vision.
This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of...
...of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance.
Additional certifications as an auditor as well as training regulatory frameworks highly desirable.
Expertise in data integrity...
Full time
