Associate Director Global Pharmacovigilance

Merck & Co.; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck & Co. is seeking an Associate Director to lead our Global Pharmacovigilance (GPV) team in Rahway, NJ. You will guide case review, aggregate reporting, and signal management while driving process excellence and staff development.

The role requires strategic leadership, strong regulatory acumen, and hands-on involvement in audits, CAPA, and PV IT applications. Hybrid work arrangements are available in this pivotal position.

Qualifications

• Must hold a PhD or DVM with 3+ years in a regulated pharmaceutical environment or a Master’s with 5+ years.
• Experience with PV systems and regulatory requirements for veterinary medicines.

Responsibilities

• Lead and manage Global Pharmacovigilance team members, overseeing case review, aggregate report preparation, and signal management.
• Establish team priorities, allocate resources, and track progress to meet timelines.
• Participate in Global PV Leadership team meetings and support regulatory audits and CAPA management.
• Provide expert support to national PV teams to ensure global alignment and compliance.
• Oversee training programs for GPV staff and relevant personnel.

Skills

Adaptability

Adverse Event Report

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

None

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.

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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.

Salary Range:

$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.

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

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

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