Senior Specialist, Global Pharmacovigilance

Job Description

Our Animal Health Research & Development team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges.

We are seeking a Growth and Improvement minded Global Animal Health Pharmacovigilance Senior Specialist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunitie and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

Our company's (AH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.

Key Functions

• Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Case review/approval for assigned products

• Expedited case submission according to timelines outlined in applicable regulations

• Case entry for non-PV-Works countries for assigned products

• Aggregate report preparation and submission to National Teams or Competent Authorities according to timelines outlined in applicable regulations

• Support national PV teams as applicable

• Product expert for assigned products

• Provide qualified answers to questions raised by internal or external stakeholders (e.g., Competent Authorities) for products for which the Senior Specialist is responsible

• PV Statement preparation in compliance with relevant regulations, policies, and procedures

• Same/similar designation of assigned products

• Allocation of new product activated in PV-Works to the applicable product family

• Risk management for assigned products

  • Participation in signal management activities, including signal detection, prioritization, validation, assessment, and recommendation for action

  • Signal management statement preparation and, if applicable, submission to Competent Authorities according to timelines outlined in applicable regulations

  • Analysis of peer-reviewed literature

  • Review of clinical study data

  • Participation in risk communication planning

  • Participation in the design and/or fulfillment of supplementary monitoring activities

  • Development of risk minimization strategies

• Archive all relevant documents/communications as agreed or defined in the applicable procedures

Additional Functions

• Participation in team meetings and audits/inspections

• Support CAPA completion activities, GPV procedure management and training

• Provide business support for pharmacovigilance database systems (e.g., review validation documents and execute User Acceptance Tests (UATs) for functionality changes)

• Conduct literature searches

• Function as Content Lead for one or more GPV sub-teams (e.g., training, risk management, procedure management)

  • Establish team priorities and allocate resources accordingly

  • Provide oversight of team projects/activities, including tracking progress and compliance with projected timelines

  • Facilitate group meetings

  • Manage team questions and engage in problem solving to address concerns as they arise

  • Consult PVLT for guidance and feedback on team activities

• Participation in projects as agreed with the manager

Education

• DVM or PhD in a clinically/scientifically relevant field or

• Master's degree in Science or equivalent in a clinically/scientifically relevant field with three years in a highly regulated pharmaceutical field

• Bachelor's degree in Science or equivalent in a clinically/scientifically relevant field with five years in a highly regulated pharmaceutical field

Preferred

• Knowledge of regulations governing pharmacovigilance for veterinary medicines

• Experience with PV databases

• Strong analytical, communication, and writing skills

• Experience with biostatistics and epidemiological principles

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Who we are …

We are known as Merck & Co., Inc., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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

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Pay Transparency Nondiscrimination

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.

Residents of Colorado:

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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:

Relocation:

VISA Sponsorship:

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Flexible Work Arrangements:

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Requisition ID:R203840