Senior Manager- Drug Safety Operations & Partnerships

Ascend Project Management, Inc.; Dublin; Hybrid; EUR 90,000 - 150,000; Full time

Job summary

Ascend Project Management, Inc. seeks a Senior Manager for Drug Safety Operations & Partnerships to develop strategic solutions for GPS, focusing on external partnerships and regulatory alignment. The role oversees lifecycle management of partnerships and supports large-scale organisational change.

The position is a 12-month contract, largely hybrid with occasional travel to the North Dublin office. Senior leadership guidance and impactful process improvements are key aspects of the role.

Qualifications

• Master's degree with at least 4 years of relevant experience; bachelor's degree with 6 years; associate degree with 10 years; or high school diploma/GED with 12 years of directly related experience.
• Experience with pharmacovigilance systems, drug safety processes, and regulatory requirements governing the pharmaceutical industry.
• Ability to research, interpret, and apply relevant laws, regulations, and industry standards, with experience supporting audits, inspections, and compliance initiatives.
• Experience in drafting, reviewing, negotiating, and managing contracts, safety agreements, or other formal external partnership documentation.
• Strong analytical and critical-thinking skills, with the ability to interpret complex information, assess risks, solve problems, and develop effective business solutions.
• Demonstrated ability to lead complex projects, manage cross-functional initiatives, prioritise competing demands, and deliver results within agreed timelines.
• Excellent written and verbal communication, negotiation, and relationship-management skills, with the ability to influence stakeholders and advise senior leaders in a matrixed environment.
• Strong attention to detail, time management, and prioritisation skills, alongside proficiency in Microsoft Office applications.

Responsibilities

• Develop, implement, and manage global external relationships, ensuring alignment with organisational objectives, functional capabilities, and regulatory requirements.
• Lead the development, negotiation, documentation, and maintenance of safety agreements with external business partners, ensuring clear roles, responsibilities, and compliance with applicable regulations.
• Lead cross-functional and international initiatives to improve partnership management, drive organisational change, and support the execution of GPS strategies and objectives.
• Evaluate performance metrics, identify opportunities for increased efficiency, and lead the design and implementation of improved processes for managing external relationships.
• Develop inspection readiness plans, identify and mitigate compliance gaps, support internal and external pharmacovigilance audits, and oversee corrective action plans to address inspection findings.
• Provide strategic advice to senior management on partnership development, operational performance, risk management, and the ongoing development and execution of GPS strategies.

Skills

Analytical thinking

Communication skills

Negotiation

Relationship management

Leadership

Education

Master's degree with 4+ years

Bachelor's degree with 6+ years

Associate degree with 10+ years

High school diploma/GED with 12+ years

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

We are working with a major Life Sciences company to recruit a Senior Manager- Drug Safety Operations & Partnerships. This person will be responsible for developing and implementing strategic solutions to complex organisational challenges within Global Patient Safety (GPS), with a focus on managing external business relationships, driving operational improvements, and supporting large-scale organisational change. This role oversees the development and lifecycle management of external partnerships, ensures alignment with regulatory and contractual requirements, and provides strategic guidance to senior leadership. The position also plays a key role in strengthening operational processes, improving performance, and maintaining inspection readiness across pharmacovigilance activities.

This is a 12 month contract role, mostly hybrid with occasional travel to the office in North Dublin.

Key Responsibilities

• Develop, implement, and manage global external relationships, ensuring alignment with organisational objectives, functional capabilities, and regulatory requirements.
• Lead the development, negotiation, documentation, and maintenance of safety agreements with external business partners, ensuring clear roles, responsibilities, and compliance with applicable regulations.
• Lead cross-functional and international initiatives to improve partnership management, drive organisational change, and support the execution of GPS strategies and objectives.
• Evaluate performance metrics, identify opportunities for increased efficiency, and lead the design and implementation of improved processes for managing external relationships.
• Develop inspection readiness plans, identify and mitigate compliance gaps, support internal and external pharmacovigilance audits, and oversee corrective action plans to address inspection findings.
• Provide strategic advice to senior management on partnership development, operational performance, risk management, and the ongoing development and execution of GPS strategies.

Key Requirements

• Master's degree with at least 4 years of relevant experience; bachelor's degree with 6 years; associate degree with 10 years; or high school diploma/GED with 12 years of directly related experience.
• Strong understanding of pharmacovigilance systems, drug safety processes, and the regulatory requirements governing the pharmaceutical industry.
• Ability to research, interpret, and apply relevant laws, regulations, and industry standards, with experience supporting audits, inspections, and compliance initiatives.
• Experience in drafting, reviewing, negotiating, and managing contracts, safety agreements, or other formal external partnership documentation.
• Strong analytical and critical-thinking skills, with the ability to interpret complex information, assess risks, solve problems, and develop effective business solutions.
• Demonstrated ability to lead complex projects, manage cross-functional initiatives, prioritise competing demands, and deliver results within agreed timelines.
• Excellent written and verbal communication, negotiation, and relationship-management skills, with the ability to influence stakeholders and advise senior leaders in a matrixed environment.
• Strong attention to detail, time management, and prioritisation skills, alongside proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.

Due to the high volume of applications, we may not be able to respond to every applicant.

AscendPM do not forward candidate CVs to clients without prior consent.