Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk
Tap Growth ai
- Cambridge, MA
- Permanent
- Full-time
⏰ Work Mode: Work From Office
💼 Role: Senior Manager, Quality Standards and Compliance, Global Patient Safety & Risk
Pay Scale: $183, 040 – $228, 800(Dependent on Experience)What You'll Do:
· Oversight and maintenance of the PSMF including provision of content to support PSMF
requirements, as assigned
· Act as a key point of contact between GVP Quality Assurance and GPSRM to ensure collaboration
between the departments
· Collaborate with GVP Quality Assurance to ensure the completion of annual pharmacovigilance
risk assessments and development of the annual audit plan
· Support PV audit activities on behalf of GPSRM in collaboration with GVP Quality Assurance
· Support PV regulatory authority inspection activities on behalf of GPSRM in collaboration with GVP
Quality AssuranceWhat We're Looking For:
✅ Bachelor’s degree in life sciences or related field.
✅ Minimum of 5 years in the pharmaceutical or life sciences industry with a focus on PV operations,
quality, and compliance in a global environment.
✅ Knowledge of relevant global pharmacovigilance guidance and regulations (e.g. FDA, EMA, MHRA,
Health Canada and International Conference on Harmonisation (ICH) guidelines, including Good
Vigilance Practices (GVP) guidelines). Experience in rare diseases therapeutic area at a global level is
an advantage.
✅ Demonstrates expertise related to understanding the principles and application of quality and
regulatory compliance
✅ Demonstrates ability to effectively communicate and influence the outcomes of the decision-
making processReady to make an impact? 🚀 Apply now and let's grow together!