Job Description

Job Description

The Pharmacovigilance (PV) Quality and Compliance Management Executive Director provides leadership in the areas of PV operations, quality management system, compliance and innovation. The incumbent also oversees the implementation and monitoring of processes to ensure high quality and compliant reporting of individual case and aggregate safety reports in accordance with PV regulations. The Executive Director is accountable for the implementation of necessary processes to ensure quality of individual case and aggregate safety reports and compliant reporting in accordance with PV regulations. This role is responsible for directing and overseeing a PV team which supports these processes and working cross-functionally to maintain standards for pharmacovigilance activities to ensure patient safety.

Primary Responsibilities

* Formulate and drive the vision for PV quality and compliance.

* Ensure alignment with vision and strategy for the safety operations organization

* Energize, motivate and establish a high performing team to aspire to excellence.

* Oversee a team performing functions to ensure high quality and compliant reporting of individual case and aggregate safety reports in accordance with PV regulations.

* Accountable for all aspects of performance management of the PV Quality and Compliance team.

* Responsible for the selecting, training, and supervising of direct reports including performing annual reviews.

* Promote understanding and education of relevant PV regulation with all of companys business units to ensure quality, compliance and patient safety

* Represent the organization in key external discussions to shape global regulatory and safety science for the entire industry.

* Provide input and review of relevant responses to regulatory agency questions with regards to quality management system and reporting compliance of individual case and aggregate safety reports.

* Lead various important pharmacovigilance process, IT and quality initiatives

* Establish key performance indicators and implement corrective and preventative actions as appropriate

* Monitor metrics related to individual case and aggregate safety reports and ensure effective implementation of appropriate action plans by liaising with other stakeholders as appropriate to address compliance and quality issues.

* Accountable for the implementation of new or updated PV regulations regarding individual case and aggregate safety reporting to ensure regulatory reporting compliance and quality.

* Resolve complex technical and operational problems

* Collaborates internally and externally on processes that ensure compliance with local and global PV regulations.

* Collaborate closely with IT and engage team members as appropriate to implement system improvements and updates of PV systems

* Serve as the primary point of contact for activities related to quality and reporting compliance of safety reports and as subject matter expert for these topics during audits and inspections

* Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.

* Provide quality and compliance oversite of external BPO partner to ensure high quality and compliant deliverables.

* Partner closely with manufacturing quality to ensure robust and high quality interfaces between quality groups.

* Drive the use of robotic process automation to streamline the capture and reporting of KPI & KQI data.

Education Requirement:

* Master's degree or bachelors degree in a life science/health care/pharmaceutical related field.

Required:

* Minimum of 10 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities

* Minimum 5 years of experience supervisory/managing/leading

* Leadership skills in working with all levels of management and consulting with key business stakeholders

* Demonstrated ability to innovate and drive successful transformational change in the PV space

* Strong knowledge base of PV regulations, in-depth understanding of business process, as well as safety systems for collections of adverse experiences.

* Regulatory Agency inspection experience

* Experience overseeing external BPO activities.

* Significant experience in partnering closely with manufacturing quality

NewCo

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R71118