Associate Director Global Pharmacovigilance

Merck; Rahway (NJ); Hybrid; USD 129,000 - 191,000; Full time

Job summary

Merck is seeking an Associate Director to lead the Global Pharmacovigilance (GPV) team. You will oversee a dedicated group responsible for case review, signal management, audits, and CAPA readiness, ensuring compliant and efficient safety operations.

The role emphasizes developing people, driving process excellence, and partnering with global PV leadership. It requires advanced degrees and substantial experience in regulated pharmacovigilance; hybrid work is supported.

Qualifications

• PhD or DVM with 3 years in regulated pharma.
• Master's with 5 years in regulated pharma.

Responsibilities

• Lead and manage Global Pharmacovigilance team members, overseeing activities such as case review and approval, aggregate report preparation, and signal management
• Establish team priorities, allocate resources effectively, and track progress to ensure all timelines and objectives are met
• Participate as needed in Global PV Leadership team meetings
• Support and participate in regulatory audits and inspections, including readiness preparation and management of CAPAs
• Ensure robust procedure management for all Global PV documents
• Support the safety database and PV IT applications, including testing
• Provide expert support to national PV teams to ensure global alignment and compliance
• Monitor and apply new legislation governing pharmacovigilance to ensure ongoing compliance
• Oversee a comprehensive training program for GPV staff

Skills

Adaptability

Adverse Event Reporting

Audit Inspections

Compliance Monitoring

Data Management

Pharmacovigilance

Process Improvements

Regulatory Compliance

Regulatory Reporting

Strategic Planning

Training and Development

Education

PhD or DVM with 3 years experience in a highly regulated pharmaceutical field

Master's degree with 5 years experience in a highly regulated pharmaceutical field

Tools

Pharmacovigilance databases

PV IT applications

Job description

Job Summary

We are seeking a dynamic and experienced leader to join our Global Pharmacovigilance (GPV) team as an Associate Director. In this critical role, you will lead a dedicated team responsible for a wide range of pharmacovigilance activities. You will be instrumental in ensuring our operations are compliant, efficient, and consistently meet the highest standards of quality and safety. The ideal candidate will be a strategic thinker with a passion for developing people and driving process excellence.

Job Description

We are seeking a dynamic and experienced leader to join our Global Pharmacovigilance (GPV) team as an Associate Director. In this critical role, you will lead a dedicated team responsible for a wide range of pharmacovigilance activities. You will be instrumental in ensuring our operations are compliant, efficient, and consistently meet the highest standards of quality and safety. The ideal candidate will be a strategic thinker with a passion for developing people and driving process excellence.

Key Responsibilities

• Lead and manage Global Pharmacovigilance team members, overseeing activities such as case review and approval, aggregate report preparation, and signal management
• Establish team priorities, allocate resources effectively, and track progress to ensure all timelines and objectives are met
• Participate as needed in Global PV Leadership team meetings
• Support and participate in regulatory audits and inspections, including readiness preparation and management of Corrective and Preventive Actions (CAPAs)
• Responsible for participation in or support/oversight of one or more of the activities described below:
• Ensure the creation, review, and maintenance of a robust procedure management process for all Global PV documents
• Support the safety database and other PV IT applications, including participation in business-related tasks such as IT application testing
• Provide expert support to national PV teams as needed to ensure global alignment and compliance
• Monitor, interpret, and apply new and existing legislation governing pharmacovigilance to ensure ongoing compliance
• Oversee a comprehensive training program for GPV staff and other relevant personnel

Leadership Expectations

We are looking for a leader who excels in fostering a culture of excellence and growth. The successful candidate will be expected to demonstrate core leadership skills, including:

• Mentoring & Coaching: Actively manage team questions, facilitate group meetings, and provide guidance to develop the skills and careers of your team members
• Continuous Learning: Stay current with evolving legislation and maintain a robust training program to ensure your team remains at the forefront of the field
• Proactive Problem Solving: Engage directly in resolving challenges as they arise and implement effective risk minimization strategies to prevent future issues
• Continuous Improvement & Innovation: Drive the enhancement of our processes and systems by participating in new projects and consistently seeking opportunities for innovation

Required Qualifications

• PhD or DVM with 3 years experience in a highly regulated pharmaceutical field; OR
• Master's degree with 5 years experience in a highly regulated pharmaceutical field

Desired Qualifications

• Experience with statistical analyses
• In-depth knowledge of regulations governing pharmacovigilance for veterinary medicinal products
• Proficiency with pharmacovigilance databases and other IT applications
• Strong analytical, communication, and writing skills

Required Skills

Adaptability, Adverse Event Report, Audit Inspections, Compliance Monitoring, Data Management, Pharmacovigilance, Process Improvements, Regulatory Compliance, Regulatory Reporting, Strategic Planning, Training and Development

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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Salary

The salary range for this role is
$129,000.00 - $203,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

09/8/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R414260