- Takeda Pharmaceuticals (Boston, MA)
- …or other relevant health-related field plus 10+ years of relevant experience in drug safety / pharmacovigilance , or related fields. + Excellent communication ... and Education function, you will report to the Senior Director , Signal Management and represent the pharmacovigilance ...English. + Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.… more
- Merck (Boston, MA)
- …the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and ... PV regulation with all of company's business units to ensure compliance and patient safety . + Assist in the development and leadership of team members. + Develop and… more
- Takeda Pharmaceuticals (Boston, MA)
- …with requisite global and local regulations and requirements. As part of the Patient Safety & Pharmacovigilance (PSPV) team, you will report to the Director ... motivating and developing people. + Expert knowledge of clinical trial and Pharmacovigilance methodologies including safety profile and risk/benefit analysis. +… more
- AbbVie (Boston, MA)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as… more