- Sanofi Group (Waltham, MA)
- …internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs) + May represent Sanofi BIOS group externally in ... interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees, etc. + May act as the lead statistician at clinical trial level and provide support and leadership to the clinical trial team on… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ A minimum of 10 years of clinical operations, regulatory, pharmacovigilance , or other relevant biopharmaceutical industry experience, including at least 5 ... years in TMF management and inspection readiness or related position + Mastery of relevant Quality compliance processes and regulations, eg, Good Clinical Practices (GCP) and Good Documentation practices + Mastery of processes related to the maintenance of an… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …alignment amongst relevant functional groups + Review of report from Drug Safety/ Pharmacovigilance , as needed + Preparing for and participating in product Scientific ... Advisory Boards for products both marketed and in development + Complete all company and job-related training as assigned within the required timelines. **Job Requirements:** + Relevant science degree (ie, PhD, PharmD, MD; Master's degree considered based on… more
- Merck (Rahway, NJ)
- …with links into risk assessments and CAPAs as needed + Collaborate with Pharmacovigilance and Regulatory Affairs on reportable events and periodic safety updates + ... Provide expert interpretation of regulations and quality standards related to complaint handling for combination products + Drive continuous improvement initiatives across complaint processes, systems and team capabilities **Qualifications, Skills &… more
- Otsuka America Pharmaceutical Inc. (Helena, MT)
- …+ Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on ... an ongoing basis including new hire and POAs, and the Field Medical Center of Excellence for mentoring and sharing of best practices. **Qualifications** + Advanced degree in Pharmacy, Medicine, Biological Sciences, Health Services Research or Public Health,… more
- Chiesi (Cary, NC)
- …with maximum impact. + Partner with IT, Legal / Compliance, Regulatory, Pharmacovigilance , and other functions as needed to develop digital policies and procedures ... to ensure compliance with all laws and regulations Experience Required + 5+ years' experience in pharma marketing, at least 4 in digital/omnichannel + Previous product launch experience + A proven track record of leading successful digital marketing strategies… more
- Haleon (Warren, NJ)
- …+ 5 years+ experience in similar role with extensive knowledge in pharmacovigilance . + In-depth knowledge in causality assessment, evaluation of safety signals and ... proactive risk management strategies including management of labelling changes. + In-depth knowledge of relevant regulations and methodologies applicable to safety evaluation & risk management activities. + Knowledge of the therapeutic areas in consumer… more
- Merck (De Soto, KS)
- …Licensing Law, Medical Device Regulations, Pharmaceutical Regulatory Affairs, Pharmacovigilance , Process Improvements, Project Management, Public Affairs, Public ... Relations (PR), Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Collaborations, Vaccine Development… more
- Sanofi Group (Orlando, FL)
- …needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies Identifies data collection opportunities during ... stakeholder interactions and reports these using approved processes. Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator… more
- ThermoFisher Scientific (Waltham, MA)
- …o biostatistician analyst who performs the analysis (biostatistician I/II/III) * Pharmacovigilance (PV) work: Through close collaboration with the PV team, we ... design, analyze and report on long-term post approval safety studies with our pharma clients to provide real-world evidence of safety * Registry work: We work cross-functionally with the Engineering, Clinical Data Management and Project Management teams on all… more