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Job Information

Merck Organon - Associate Director, PV Training & Documentation in North Wales, Pennsylvania

Job Description

Position Purpose

Under the direction and oversight of the Pharmacovigilance (PV) Process and Standards Director, the Training and Documentation Lead Associate Director develops, maintains, and provides the necessary trainings and documentation of processes to ensure compliance with PV regulations. The Associate Director acts as a subject matter expert on PV regulations relevant to training and documentation.

Primary Responsibilities

  • Lead the development, delivery, implementation, maintenance and tracking of the global PV training strategy (e.g. training matrix, processes, metrics, and effectiveness verifications).

  • Manage and maintain all PV-controlled documents (e.g. PSMF, SOPs, Safety System User Manual, etc.).

  • Assist in the authoring, reviewing and implementation of new PV-controlled SOPs and supportive documents.

  • Represent PV on cross-functional initiatives and externally with business partners and vendors to ensure PV SOP alignment and compliance.

  • Provide input and review of responses to regulatory agency questions related to training and documentation procedures.

  • Participate in various important pharmacovigilance processes, IT and quality initiatives contributing to continuous process improvement of PV procedures and innovative solutions.

  • Participate in inspection readiness activities and preparation as needed.

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 PV principles, systems and requirements in addition to PV regulations

  • Experience working cross culturally and actively supporting diversity

  • Computer skill required- use of database and basic Office 365 suite applications

  • Problem solving, conflict resolution and critical thinking skills

  • Demonstrated ability to build and manage close relationships with key stakeholders within the region.

  • Proficient in Good Documentation Practices

  • Experience interacting with auditors/inspectors

#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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

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

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

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: R81053

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