Merck Senior Specialist, Global Pharmacovigilance in Madison, New Jersey
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.
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
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
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
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.
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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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R203840
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