Associate Director Global Regulatory Affairs (CMC) - Cambridge, MA 02139 (Remote)

Job Description

Job DescriptionTitle: Associate Director, Signal Management & Innovation
Location: Cambridge, MA 02139 (Remote)
Duration: 6+ Months (Possible Extension)

Department: Patient Safety & Pharmacovigilance (PSPV) / Medical Safety Sciences
Industry: Pharmaceutical / Life Sciences

Position Overview:
We are looking for an experienced pharmacovigilance professional to lead signal detection, evaluation, and management activities within a global Patient Safety organization. This role will work closely with Pharmacovigilance, Global Regulatory Affairs, Data Sciences, Medical Safety, and other cross-functional teams to ensure signal management processes meet global regulatory and compliance standards.

Key Responsibilities:

• Lead and maintain signal detection, evaluation, and management processes in accordance with global pharmacovigilance regulations.
• Provide subject matter expertise in signal detection and signal management across global and regional teams.
• Partner with Data Sciences, Global Regulatory Affairs, Medical Safety, and other PSPV functions to develop and improve signal management processes.
• Ensure signal management activities align with EU regulations and global Health Authority expectations, including inspection readiness.
• Represent Pharmacovigilance as a subject matter expert in cross-functional teams, committees, and external interactions.
• Develop and deliver training related to signal detection and management processes.
• Provide mentorship and guidance to junior/new pharmacovigilance professionals.
• Oversee signal management activities performed by external vendors.
• Lead or support projects related to signal management processes and continuous process improvement.
• Review, analyze, interpret, and present complex safety data to support appropriate decision-making.

Required Qualifications & Skills:

• Bachelor's degree or higher in Life Sciences, Healthcare, Pharmacy, Nursing, or a related field.
• Strong experience in Pharmacovigilance / Patient Safety, particularly Signal Detection and Signal Management.
• In-depth knowledge of clinical trial methodology and pharmacovigilance regulations.
• Strong understanding of signal detection, signal evaluation, and risk-benefit analysis.
• Experience working within a global PV organization and collaborating with cross-functional teams.
• Knowledge of EU pharmacovigilance regulations and Health Authority expectations is highly valuable.
• Strong analytical, critical-thinking, strategic-thinking, and decision-making skills.
• Ability to analyze and communicate complex safety data effectively.
• Excellent written, verbal, communication, and presentation skills.
• Strong documentation and organizational skills with the ability to manage multiple priorities.
• Comfortable working independently in a global, cross-functional environment.

Ideal Candidate:
The ideal candidate will be a senior-level Pharmacovigilance/Drug Safety professional with strong hands-on Signal Management experience, global regulatory knowledge, and the ability to operate as a subject matter expert across cross-functional teams