- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic ... expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support the… more
- Takeda Pharmaceuticals (Boston, MA)
- …compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by ... and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance -related change controls. + Provides data insights to emerging… more
- BeOne Medicines (Emeryville, CA)
- …leads the incorporation of latest updates and findings from ongoing pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face ... + Leads GPS product co-ordination, chairs product group meetings across GPS ** Pharmacovigilance :** + Leads and manages safety PV processes for BeiGene and competitor… more
- Merck (Rahway, NJ)
- …Procedures (SOPs), applicable regulations (eg, Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice,), safety guidelines and company ... Audit, Issue Management, Knowledge Management, Management Process, Marketing Compliance, Pharmacovigilance , Preventive Action, Problem Solving Therapy, Process Improvements, Professional… more
- Bristol Myers Squibb (Pittsburgh, PA)
- …provide key scientific updates to internal stakeholders (eg Commercial, Regulatory, Pharmacovigilance , Legal, HEOR, Value Access & Payment) + Provide scientific ... agreed upon with home office medical and GDO + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies,… more
- Medexus Pharma (PA)
- …regulatory and ethical standards. + Collaborate cross-functionally with Regulatory, Pharmacovigilance , Quality, and Commercial teams to ensure aligned, compliant ... Knowledge of medical affairs processes, regulatory compliance (GCP, FDA/EMA), pharmacovigilance , and safety reporting. + Excellent written, verbal, and interpersonal… more
- Lilly (Indianapolis, IN)
- …+ Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. + Serve as an IT systems business quality ... + 2+ years experience in a quality control/quality assurance role supporting Pharmacovigilance (PV) + Experience in defined functional business areas, for example,… more
- US Tech Solutions (IL)
- …effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing ... experience working with stat programmers, statisticians, data management personnel and Pharmacovigilance stakeholders. * Oversee and responsible for the creation and… more
- AbbVie (North Chicago, IL)
- …study protocols and informed consents. When appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, ... residency with patient management experience 2. 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry 3. Effectively… more
- CSL Behring (King Of Prussia, PA)
- …establish and maintain global standards, policies, and governance frameworks for pharmacovigilance (PV) data and processes. You will ensure compliance, consistency, ... Public Health, or a related field + 10+ years of experience in pharmacovigilance , safety data management, or regulatory affairs + Knowledge of global PV… more