Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Senior Pharmacovigilance Specialist performs those activities essential to ensuring the quality and compliance of adverse experience information. Senior PV Specialist stays current on existing and emerging regulations and guidance’s pertaining to pharmacovigilance. On a continual basis, actively works to incorporate operational excellence principles into processes related to adverse experience processing and management to ensure optimal compliance.
Primacy Activities include but are not limited to:
- Performs unblinding of clinical trial cases and liaises with key cross functional areas (Clinical, Risk Management, and Regulatory) to ensure accurate and timely submission of 7 and 15 day expedites to global Health Authorities.
- Performs compliance monitoring activities for expedited individual case submissions to regulatory agencies. Performs detailed investigations for late submissions and liaises with appropriate business parties as appropriate.
- Performs compliance monitoring activities specific to Business Partners. Maintains working knowledge of licensing agreements and tracks and monitors reports sent late to agencies as a result of late partner adverse experience (AE) information exchanges. Monitors Partners’ compliance to the agreements and compiles metrics which are provided to Partners on a monthly basis.
- Ensures robust documentation of root cause and corrective and preventative actions (CAPAs) for late reports to regulatory agencies as well as late reporting by Partners to Merck per agreement timeframes
- Compiles compliance metrics for review by Senior Management and Case Processing Providers.
- Provides expert guidance to case processing providers’ areas on policies and procedures governing the processing of adverse experience information.
- Works with Senior Management and Documentation Unit to identify and prioritize requirements for new and updated sections of User Manual, Standard Operating Procedures, and training material in relation to new and/or improved business processes and evolving worldwide regulatory requirements.
- Performs quality review of a sampling of adverse experience reports to ensure adherence to global case processing standards. Identifies, prioritizes, and monitors quality issues to be resolved to maintain compliance.
- Compiles quality metrics for review by Case Processing Providers and Senior Management.
- Reviews study protocols and AE monitoring plans for AE requirements and liaises with business partners to ensure compliance.
Education Minimum Requirement:
- Bachelor’s degree or master’s degree in health care/pharmaceutical related field or project management.
Required Experience and Skills:
- Candidate is required to have three years of safety experience or related areas such as Clinical Risk Management, Clinical or Regulatory.
Preferred Experience and Skills:
- Strong knowledge base of pharmacovigilance principles with close attention to detail and ability to be flexible in order to meet daily competing priorities of the business.
- Candidate should be extremely organized with strong documentation and analytic skills.
- Demonstrates leadership, and excellent communication and interpersonal skills.
- Ability to project manage and independently drive projects to completion.
- Strong knowledge of and experience with advanced MS Excel and Access.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Drug/Dvcs Sfty Survnce (NonMD)
Job Title: Sr. Spclst, Drug Safety
Primary Location: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Number of Openings: 4
Shift (if applicable): 1st
Company Trade Name: Merck