- Lilly (Indianapolis, IN)
- …government, and academia. The candidate will develop key skills in pharmacovigilance and safety science (particularly with respect to novel methodologies), have ... extensive professional networking opportunities via collaborations with colleagues in Medical, Statistics, Toxicology, and Advanced Intelligence, gain experience in the pharmaceutical industry at multiple lifecycle stages, and leverage opportunities to share… more
- Sanofi Group (Swiftwater, PA)
- …of other functions providing input to clinical documents (biostatistics, pharmacovigilance , clinical development, regulatory, etc.) + Collaborative experience with ... external partners providing resources or expertise with contract research organizations (CROs), key opinion leaders (KOLs), vendors, etc. + Strong leadership ability, coupled with strategic and innovative thinking. + Proven ability to manage people, budgets… more
- AbbVie (North Chicago, IL)
- …data sources (biomarker/translational, big data, digital sources, real world data, pharmacovigilance data, clinical trial data) + Responsible for coaching, mentoring ... and performance management of direct reports. Responsible for talent development in alignment with R&D business needs + Represents the functional area at critical governance, quality and compliance, and regulatory meetings + Ensures consistent analytics… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes final decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and compounds in conjunction with Pharmacovigilance . + **External Interactions** + Directs activities involved in interactions ... with regulatory authorites/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these… more
- ThermoFisher Scientific (Wilmington, NC)
- …practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with ... key areas of interest and hot topics. + **Communication:** Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences. Publish relevant selected content to internal Engage forum. +… more
- Sumitomo Pharma (Trenton, NJ)
- …for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of ... clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and… more
- Sanofi Group (Cambridge, MA)
- …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
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming ... regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …organization including, but not limited to, clinical compliance and pharmacovigilance , electronic systems and laboratory compliance, and quality documents and ... training administration. + Provide oversight to Medical Affairs quality and governance and collaborate with Gilead's Chief Compliance Officer on healthcare compliance execution. + Promote a culture of GxP quality across R&D with the highest levels of integrity… more