Merck Associate Director, Drug Safety in Upper Gwynedd, Pennsylvania
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
• Develop standards and processes to ensure Pharmacovigilance (PV) compliance and quality in company business activities such as commercial activities (patient programs, digital and social media activities), non-interventional studies and clinical trials.
• Ensure that PV requirements are supported by robust procedures (e.g., templates, standards, etc.)
• Collaborate cross-divisionally to promote understanding and education of PV legislation with all of company’s business units to ensure compliance and patient safety; and provide expert guidance on policies and procedures related to PV requirements.
• Develop and implement strategies aiming to promote the mission and vision of organization
• Lead core activities tied to PV requirements to ensure standardization and optimization of standards and processes.
• Assist in preparing and responding to Regulatory Agency Inspections as well as internal and external audits.
• Collaborate with and maintain effective working relationships with Global Pharmacovigilance community and external customers to ensure regulatory compliance of PV requirements.
• Interpret FDA and EU regulations and ICH guidelines to ensure compliance globally
• Assist in the development and leadership of team members.
• Ensure company policies and legal guidelines are followed at all times
• Support any other project or perform any other task deemed appropriate by management.
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 a minimum of five years of safety experience or related areas such as Medical Affairs, Regulatory Affairs, Compliance, or Clinical Research
• Strong knowledge base of pharmacovigilance principles
Preferred Experience and Skills:
• Demonstrated leadership and proficiency managing across organizations
• Ability to independently manage and drive projects to completion
• Strategic vision
• Ability to engage cross-functional stakeholders
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Drug/Dvcs Sfty Survnce (NonMD)
Title: Associate Director, Drug Safety
Primary Location: NA-US-PA-Upper Gwynedd
Requisition ID: DRU001002
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