Senior Manager, Pharmacovigilance Quality & Regulatory Compliance

🌟 We're Hiring : Senior Manager, Quality Standards and 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)

What You'll Do :

• Oversight and maintenance of the PSMF including provision of content to support PSMF

requirements, as assigned

between the departments

risk assessments and development of the annual audit plan

Quality Assurance

What 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 process

Ready to make an impact? 🚀 Apply now and let's grow together!