Associate Director, PV Systems Support / Oss

Organisatie: MSD
Locatie: Oss
Functie: Associate Director, PV Systems Support
Vervaldatum: 24/05/2021
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Job Description

Associate Director – PV Systems Support, USPV&GS manages activities related to the successful maintenance and implementation of multiple applications across the safety landscape. The incumbent provides technical support for the necessary tools to ensure high quality and compliant PV processes performed within Global Clinical Safety and Pharmacovigilance. The Associate Director collaborates with internal and external stakeholders to ensure that system updates and implementations are compliant with local and global PV regulations.

Responsibilities:

  • Develop and implement strategies aiming to promote the mission and vision of organization.

  • Maintain robust understanding of the overall safety technology landscape, including key system interdependencies and external interfaces.

  • Assist Business Systems Lead(s) as needed to ensure a clear understanding of technical changes and the associated risk for effective tailoring of SDLC deliverables.

  • Manage User Acceptance Testing (UAT) related activities such as assessing UAT needs, developing and communicating high-level UAT plans

  • Coordinate UAT by identifying testers for UAT, ensuring proper training is completed, develop test cases, track issues during testing and ensure proper documentation is completed prior to deployment.

  • Work with IT and support team to create user provisioning and deprovisioning process and monitor metrics and issues, identify needs for improvement based on feedback.

  • Provide guidance to the lobal safety organization in prioritizing IT projects with the goal of achieving the best return-on-investment from our IT initiatives.

  • Act as an agent of the business with respect to IT engagements to provide assessments of proposed technology solutions.

  • Enable PV business process improvement and strategy realization through technology enablement and ensure on-going operations and compliance through day to day business system operations.

  • Perform impact assessment for system related updates, case intake, processing and reporting, signal management, aggregate reporting and analytics.

  • Provide practical knowledge of current technologies and processes to innovate and identify new capabilities and enhancement opportunities to improve safety management business operations.

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

  • Ensure company polices and legal guidelines are followed at all times.

  • Support any other project or perform any other task based on business need and deemed appropriate by management.

  • Assist in the development and leadership of team members.

  • Education:

  • Bachelor’s degree or master’s degree in a business, scientific, or technology discipline relevant to the life sciences and/or information technology areas

  • Required Experience:

  • Minimum of 3 years of Pharmacovigilance (PV) business or systems experience within a regulatory and clinical safety organization

  • At least three years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support

  • Strong working knowledge of PV regulations and safety systems for collection and analysis of adverse event information

  • Experience with managing vendor deliverables

  • Excellent written and verbal communication skills

  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

  • Preferred:

  • Experience with Argus Safety or RxLogix PV Suite of systems

  • Project management capabilities

  • Functions with a high degree of autonomy

  • Ability to engage and lead cross-functional stakeholders both internal and external

  • Ability to identify potential compliance gaps and process inefficiencies that can be eliminated through process re-engineering or technological solutions.

  • Background in software development/coding (any language) and/or relational database design/SQL

  • 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 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

    Current Contingent Workers apply

    Secondary Language(s) Job Description

    Education:

  • Bachelor’s degree or master’s degree in a business, scientific, or technology discipline relevant to the life sciences and/or information technology areas
  • Required:

  • Minimum of 3 years of Pharmacovigilance (PV) business or systems experience within a regulatory and clinical safety organization
  • At least three years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support
  • Strong working knowledge of PV regulations and safety systems for collection and analysis of adverse event information
  • Experience with managing vendor deliverables
  • Excellent written and verbal communication skills
  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
  • Preferred:

  • Experience with Argus Safety or RxLogix PV Suite of systems
  • Project management capabilities
  • Functions with a high degree of autonomy
  • Ability to engage and lead cross-functional stakeholders both internal and external
  • Ability to identify potential compliance gaps and process inefficiencies that can be eliminated through process re-engineering or technological solutions.
  • Background in software development/coding (any language) and/or relational database design/SQL
  • 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 if you need an accommodation during the application or hiring process.

    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:

    No Travel Required

    Flexible Work Arrangements:

    Remote Work

    Shift:

    1st – Day

    Valid Driving License:

    Hazardous Material(s):

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