- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …is preferred (MS, Pharm.D.) + At least one year of relevant experience in pharmacovigilance , clinical research, or regulatory affairs in a CRO or a ... guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess autonomy and… more
- Amgen (Washington, DC)
- … safety / pharmacovigilance experience OR Bachelor's degree and 6 years of safety / pharmacovigilance experience OR Associate degree and 10 safety / ... Supports and provides oversight to staff with regards to safety in clinical trials to: + Review...qualifications. **Basic Qualifications:** Doctorate degree and 2 years of safety / pharmacovigilance experience OR Master's degree and… more
- AbbVie (North Chicago, IL)
- …reports (PSUR's, PADER's etc.) + Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing. + ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing ... + Safety issue management + Set-up of safety analyses in both post marketing and clinical...as appropriate + Provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance… more
- Taiho Oncology (Princeton, NJ)
- …collaboration with team members. + Maintain training and oversight to clinical operations/ pharmacovigilance vendors supporting pharmacovigilance activities, ... Associate Director, PV Sciences Pleasanton, CA, USA *...and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... Clinical Trial Support** + Lead the review of safety data and monitor the safety of...**Supervisory Responsibilities:** This position has no direct reports. The Associate Director, Safety Scientist is part of… more
- J&J Family of Companies (Spring House, PA)
- …Relevant work experience as Medical Monitor, and/or pharmacovigilance and/or drug safety officer in a CRO, pharma/biotech. Early Clinical Development and ... Associate Director, Translational Clinical Medical Lead...core a deep collaboration between Disease Area experts, CPP, Clinical and Non- Clinical Safety , Translational… more
- Merck (Columbus, OH)
- **Job Description** **Position Description:** ** Associate Clinical Research Associate - Northeast Region (Remote)** With support of Senior Clinical ... contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. +...are complete, accurate and unbiased + o Subjects' right, safety and well-being are protected + Conducts site visits… more
- WCG Clinical (Indianapolis, IN)
- …to global user's access. + Processes global user's system access to the clinical safety notification distribution portal + Ensures the company continuously meets ... Clinical Systems Associate Data Manager (Remote)...the required safety reporting requirement timelines set forth by the FDA...as part of a team + Experience with a Pharmacovigilance system such as Aris or Argus is a… more
- Lilly (Indianapolis, IN)
- …volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage clinical and scientific expertise ... pharmacovigilance , regulatory affairs + Experience within Global Patient Safety or demonstrated knowledge and understanding of pharmacovigilance ,… more
- Ascendis Pharma (Palo Alto, CA)
- …drug safety required. + Minimum of 8 years recent experience in Pharmacovigilance required + Expert knowledge of FDA safety regulations, ICH Guidelines, and ... The Associate Director Global PV Operations reports directly to the Sr Director, Medical Safety Science-Oncology. Under the direction of the Sr Director, Medical… more
- ThermoFisher Scientific (Greenville, NC)
- …are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client ... is accurate and complete. Contributes to departmental process improvement initiatives. ** Clinical Trial Support:** Monitors all safety variables (AE, laboratory… more
- Randstad US (Cambridge, MA)
- senior safety associate iii. + cambridge , massachusetts + posted april 26, 2024 **job details** summary + $50.72 - $57.58 per hour + contract + bachelor degree ... hours: 9 to 5 education: Bachelors responsibilities: The Senior Safety Associate III will be responsible for...Case Processing (data entry and quality review) of both Clinical Trial and Post-marketing ICSRs + Advanced proficiency in… more
- IQVIA (Falls Church, VA)
- ** Associate Principal, Epidemiology and Drug Safety , Real World Evidence** Remote; candidates must be based in the US. **About Our Team** The Epidemiology and ... Drug Safety practice at IQVIA is a fast-growing component of...team of researchers with backgrounds in epidemiology, regulatory science, pharmacovigilance , and health services research. **Overview of the Role**… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our ... PADERs + Development Safety Update Reports + Risk Management Plans + Clinical Overview Statements + Continuous monitoring and further development of the product … more
- Sanofi Group (Cambridge, MA)
- …at the investigator meetings + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety , stat outputs of blinded data, ) ... study report + Take on as necessary the Associate CRD role: + Develop the abbreviated protocol +...Clinical Scientists, Medical review team and Coding + Pharmacovigilance (GSO, CME) + CTOMs, Biostatisticians + CSU medical… more
- AbbVie (North Chicago, IL)
- …pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for ... and responses, and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on… more
- Merck (North Wales, PA)
- …and other type of agreements related to clinical research. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare ... through research and innovation. Through clinical trials and surveillance, we ensure the ...of relevant experience in the pharmaceutical industry or an Associate 's Degree with a minimum of 5 years of… more
- ThermoFisher Scientific (Wilmington, NC)
- …are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client ... is accurate and complete. + Contributes to departmental process improvement initiatives. Clinical Trial Support: + Monitors all safety variables (AE, laboratory… more
- ThermoFisher Scientific (Greenville, NC)
- …are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client ... ensure that the medical content is accurate and complete. ** Clinical Trial Support:** + Monitors all safety ...1-2 years) in the industry. + Direct experience in safety / Pharmacovigilance (comparable to 2 years). + Candidates… more