Tap Growth ai
Senior Manager, Pharmacovigilance Quality & Regulatory Compliance
Tap Growth ai, Cambridge, Massachusetts, us, 02140
Senior Manager, Pharmacovigilance Quality & Regulatory Compliance
We are seeking an experienced Senior Manager to lead quality standards and compliance initiatives within our Global Patient Safety & Risk division. The ideal candidate will drive regulatory compliance, establish quality frameworks, and ensure patient safety across all operations while collaborating with cross‑functional teams.
Location:
Cambridge, MA 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)
Responsibilities
Oversight and maintenance of the PSMF including provision of content to support PSMF.
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 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 Assurance.
Qualifications
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 ICH guidelines including Good Vigilance Practices). Experience in rare disease therapeutic area at a global level is an advantage.
Demonstrated expertise related to understanding the principles and application of quality and regulatory compliance.
Demonstrated ability to effectively communicate and influence the outcomes of the decision‑making process.
Ready to make an impact?
Apply now and let's grow together!
#J-18808-Ljbffr
Location:
Cambridge, MA 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)
Responsibilities
Oversight and maintenance of the PSMF including provision of content to support PSMF.
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 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 Assurance.
Qualifications
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 ICH guidelines including Good Vigilance Practices). Experience in rare disease therapeutic area at a global level is an advantage.
Demonstrated expertise related to understanding the principles and application of quality and regulatory compliance.
Demonstrated ability to effectively communicate and influence the outcomes of the decision‑making process.
Ready to make an impact?
Apply now and let's grow together!
#J-18808-Ljbffr