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Merck & Co, Inc

Organon - Associate Director, Pharmacovigilance Quality and Compliance ( MERCUSR81044ENUS)

Aerospace and Aviation

Quality Assurance Technician

Yearly

No

Lansdale, Pennsylvania, United States

Job Description

Position Purpose

Under the direction and oversight of the )Pharmacovigilance (PV) Quality and Compliance Executive Director, the Pharmacovigilance Quality and Compliance Associate Director develops and performs the necessary processes to ensure high quality and compliant reporting of individual case and aggregate safety reports in accordance with Pharmacovigilance regulations. The Associate Director is responsible for the implementation and optimization of processes used to monitor the quality of individual case and aggregate safety reports and compliant reporting to ensure internal and regulatory compliance.

Primary Responsibilities

  • Perform quality review and compliance monitoring of individual case and aggregate safety reports to

  • Health Authorities and Business Partners adhering to regulatory requirements.

  • Measure quality effectiveness by tracking appropriate metrics and evaluating key performance indicators.

  • Partner with internal and external stakeholders to identify, prioritize and monitor quality and compliance issues and develop solutions to minimize risk and ensure the overall quality management system.

  • Responsible for the implementation of emerging regulations to ensure global alignment of quality and compliance activities and processes.

  • Collaborate with manufacturing quality to ensure robust and high quality interfaces between quality groups.

  • Assess the impact of internal procedural changes to quality and compliance monitoring activities and update of these activities to remain relevant.

  • Lead and participate in various important pharmacovigilance processes, IT and quality initiatives.

  • Responsible for ensuring that quality review and compliance activities are supported by robust procedures (E.g. Standard Operation Procedures, user manual, etc.)

  • Participate in inspection readiness activities and preparation as needed Act as a subject matter expert and provide input and review of responses to regulatory agency questions with regards to quality and compliance monitoring activities.

  • Develop and maintain tools to streamline the monitoring of quality and compliance, introducing automation where possible.

Qualification, Skills & Experience

  • Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field

  • Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities

  • Knowledge of Pharmacovigilance principles, systems and requirements in addition to Pharmacovigilance regulations

  • Strong analytical skills and quality focus

  • Problem solving, conflict resolution and critical thinking skills

  • Experience working cross culturally and actively supporting diversity

  • Demonstrated ability to build and manage close relationships with key stakeholders

  • Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.

  • Experience interacting with auditors/inspectors

  • Proficient in basic Office 365 suite applications

#NewCo

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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 another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R81044