Signal Management Operations Lead
Sanofi
6 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
Main Responsibilities:
- Maintain oversight of the signal management process, including business system ownership of signal detection and management systems.
- Evaluate and adapt Sanofi processes to ensure compliance with evolving global regulations.
- Define and execute quality document strategy aligned with global regulatory requirements and company standards.
- Represent signal management on PSPV and cross-functional working groups and continual improvement initiatives.
- Perform quality control/quality assurance of signal detection and management activities executed by employees and vendor staff.
- Develop and execute CAPAs for quality events.
- Oversee vendor operations and track KPIs.
- Serve as a subject matter expert on signal management for internal and external stakeholders to PSPV.
- Train staff on signal management processes and systems.
- Represent the function for audits and inspections (business partner and internal process/system audits).
- Define strategy for signal management acquisition and divestment data exchange.
Required Qualifications:
- Minimum 6 years of pharmacovigilance experience (additional experience an asset).
- Proven ability to lead and manage projects effectively.
- Strong facilitation and stakeholder influence capabilities (inside and outside PSPV).
- Excellent written and verbal communication skills.
- Familiarity with signal detection and management systems.
- Working knowledge of pharmacovigilance regulations (US, EU, and global).
- Master’s degree in a STEM discipline or Public Health (PharmD or other advanced life science degree is an asset).
- Fluent English (written and spoken).
Preferred Qualifications:
- People management.
- Audit and inspection presentation, execution, and strategy.
- Influencing without authority.
- Experience with Sanofi standard systems (Jira, Confluence, ServiceNow).
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.
- Maintain oversight of the signal management process, including business system ownership of signal detection and management systems.
- Evaluate and adapt Sanofi processes to ensure compliance with evolving global regulations.
- Define and execute quality document strategy aligned with global regulatory requirements and company standards.
- Represent signal management on PSPV and cross-functional working groups and continual improvement initiatives.
- Perform quality control/quality assurance of signal detection and management activities executed by employees and vendor staff.
- Develop and execute CAPAs for quality events.
- Oversee vendor operations and track KPIs.
- Serve as a subject matter expert on signal management for internal and external stakeholders to PSPV.
- Train staff on signal management processes and systems.
- Represent the function for audits and inspections (business partner and internal process/system audits).
- Define strategy for signal management acquisition and divestment data exchange.
Required Qualifications:
- Minimum 6 years of pharmacovigilance experience (additional experience an asset).
- Proven ability to lead and manage projects effectively.
- Strong facilitation and stakeholder influence capabilities (inside and outside PSPV).
- Excellent written and verbal communication skills.
- Familiarity with signal detection and management systems.
- Working knowledge of pharmacovigilance regulations (US, EU, and global).
- Master’s degree in a STEM discipline or Public Health (PharmD or other advanced life science degree is an asset).
- Fluent English (written and spoken).
Preferred Qualifications:
- People management.
- Audit and inspection presentation, execution, and strategy.
- Influencing without authority.
- Experience with Sanofi standard systems (Jira, Confluence, ServiceNow).
Benefits (explicitly stated):
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.