Merck Senior Pharmacovigilance Specialist, Remote based in Helena, Montana
Senior Pharmacovigilance (PV) Specialist, PV Business Group, collaborates with company staff to provide PV input for company processes and standards that require adverse event (AE) collection. Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements. Senior PV Specialist stays current on existing and emerging PV regulations and guidance.
This Position can be based remotely in EDT time zome .
Contribute to, and provide subject matter expertise for PV templates for clinical trial protocols to ensure compliance with global PV regulations
Review and approve PV content of clinical trial protocols
Participate in interdepartmental and interdivisional meetings in support of individual protocol reviews, input for PV requirements, and related processes
Collaborate interdepartmental to ensure PV requirements are incorporated into business processes, standards and resources
Provide support and training for relevant topics
Process incoming requests from internal and external sources related to PV requirements and initiate appropriate course of action and/or response
Maintain relevant PV standards and resources
Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits as applicable
Support any other project or perform any other task deemed appropriate by management
- Bachelor's degree or master's degree in health care or pharmaceutical related field
Candidate is required to have three years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory
Strong knowledge base of pharmacovigilance principles
Excellent communication and interpersonal skills
Attention to detail and ability to be flexible in order to meet daily competing priorities of the business
Ability to independently manage projects and drive projects to completion
Strong knowledge base of pharmacovigilance regulations
Demonstrate leadership and proficiency managing across organizations
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 .
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No Travel Required
Flexible Work Arrangements:
Remote Work, Telecommuting
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R130148