Senior Pharmacovigilance Director, Regulatory Compliance Expert

4 days ago


Étreux, Hauts-de-France, United States Edgewise Therapeutics Full time
About Edgewise Therapeutics:

Edgewise Therapeutics is a leading biopharmaceutical company focused on developing innovative medicines for serious muscle diseases. Our mission is to improve the lives of patients by harnessing our expertise in muscle biology and biophysics.

We are committed to building a strong leadership team with a track record in the biotechnology and pharmaceutical industry to drive our growth and success. As we continue to advance our product pipeline, we are seeking an experienced professional to join our team as Senior Pharmacovigilance Director, Regulatory Compliance Expert.

This role will provide strategic oversight and support for pharmacovigilance operations across our therapeutic areas, ensuring compliance with regulatory requirements and industry standards. The ideal candidate will have a deep understanding of FDA, EU, and ICH guidelines and experience with safety databases.

Key Responsibilities:
  • Oversight of medical surveillance and risk management for investigational products
  • Reporting: Lead the creation and coordination of pharmacovigilance reports (DSUR, PBRER, etc.), ensuring stakeholder input and regulatory timelines are met
  • Safety Surveillance: Perform safety surveillance, signal detection, and benefit-risk assessments
  • Collaboration: Work closely with stakeholders to ensure comprehensive safety reviews, and lead Safety Review Team meetings
  • Regulatory Compliance: Ensure compliance with regulatory and Risk Management Plan (RMP) commitments, and support clinical programs and registration activities

About the Role:

The Senior Pharmacovigilance Director, Regulatory Compliance Expert will be responsible for overseeing the development and implementation of pharmacovigilance strategies and plans to ensure compliance with regulatory requirements. This role will also involve collaborating with cross-functional teams to ensure that pharmacovigilance activities are aligned with business objectives and that regulatory obligations are met.

The ideal candidate will have a strong background in pharmacovigilance, with experience in managing pharmacovigilance activities and ensuring compliance with regulatory requirements. A proven track record of implementing effective pharmacovigilance strategies and plans is essential for this role.

About You:

We are looking for a highly motivated and experienced professional who has a passion for pharmacovigilance and regulatory compliance. The ideal candidate will have a strong educational background, preferably in a scientific field, and relevant work experience in pharmacovigilance or a related field.

You will have excellent communication and problem-solving skills, with the ability to work independently and as part of a team. Experience with safety databases and computer applications such as Microsoft Word, Excel, Microsoft Access, and Power Point is essential for this role.

Benefits:

We offer a competitive salary range of $165,000-$290,000, commensurate with experience, and a comprehensive benefits package including health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match, and paid time off. There is no deadline for application as we accept resumes on an ongoing basis.

  • Étreux, Hauts-de-France, United States BioLink 360 Full time

    About BioLink 360BioLink 360 is a global leader in diagnostic imaging agents with a diverse portfolio of products. As a pioneer in the industry, we strive to maintain the highest standards of quality, safety, and compliance.OverviewThe successful candidate will direct all global pharmacovigilance activities and safety reporting for all marketed products....


  • Étreux, Hauts-de-France, United States Page Mechanical Group Inc Full time

    Job Title: Senior Pharmacovigilance Quality and Alliance DirectorEstimated Salary: $150,000 - $180,000 per yearAbout the JobWe are seeking a highly skilled and experienced Senior Pharmacovigilance Quality and Alliance Director to join our team at Page Mechanical Group Inc. in Boston or remotely.This is an exciting opportunity for a seasoned professional with...


  • Étreux, Hauts-de-France, United States Lifelancer Full time

    About this role, we are seeking a Global Pharmacovigilance Leader to join our team. This is a unique opportunity for an experienced professional to drive the development and implementation of pharmacovigilance strategies across regions.Company OverviewLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented individuals...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewThe role of Senior Regulatory Affairs Expert, Labeling Compliance Specialist at Takeda Pharmaceutical is a pivotal position that ensures the company's products meet regulatory requirements and maintain compliance with global labeling standards.This position plays a crucial role in ensuring Takeda gains regulatory approval for new products and...


  • Étreux, Hauts-de-France, United States Global Channel Management Full time

    About the JobAs a seasoned professional in pharmacovigilance, you will be responsible for managing vendors and adverse event handling. Your expertise will be essential in ensuring compliance with global PV regulations.We are looking for an experienced individual to join our team as a Pharmacovigilance Operations Specialist. In this role, you will play a...


  • Étreux, Hauts-de-France, United States Global Channel Management Full time

    About the Job">We are seeking a highly skilled Pharmacovigilance Operations Manager to join our team at Global Channel Management. As a key member of our organization, you will play a vital role in ensuring the smooth operation of our Pharmacovigilance department.">Job Summary:">">The successful candidate will be responsible for managing vendor relationships...


  • Étreux, Hauts-de-France, United States Cognizant Full time

    Compliance Lead Position OverviewCognizant Technology Solutions seeks a seasoned QEA Compliance Lead with extensive expertise in Quality Engineering and Assurance to oversee the assessment of GxP systems, conduct risk assessments, and ensure compliance with regulatory standards.About CognizantWe're a global leader in digital transformation, serving clients...


  • Étreux, Hauts-de-France, United States Fidelity TalentSource LLC Full time

    About the Role">This role is a key part of Fidelity Digital Asset Services, LLC's Compliance team. As a trusted business partner, you will promote a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.You will support regulatory oversight of FDAS, collaborating closely with various teams within FDAS and across the...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Pharmaceutical Technical Leadership RoleThis leadership position plays a pivotal role in shaping the pharmaceutical industry's regulatory landscape. As a Senior Regulatory Expert, you will lead efforts to define and implement external engagement strategies, governance, and associated capabilities for Takeda Pharmaceutical.Key Responsibilities:Develop and...


  • Étreux, Hauts-de-France, United States MFS Investment Management Full time

    About the RoleMFS Investment Management is seeking a skilled Senior Communications Specialist to join our Global Distribution Communication Oversight Team (GDCOT). This role will be responsible for monitoring and reviewing electronic communications of assigned employees to ensure compliance with FINRA, SEC, and internal guidelines. As a Registered Principal,...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    **Job Summary:** We are seeking an experienced Lead Regulatory Expert to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success for...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    **Job Description:**We are seeking an experienced Regulatory Affairs Director to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewAs a Senior Technical Regulatory Advisor at Takeda Pharmaceutical, you will be responsible for defining and implementing an external engagement strategy, governance, and associated capabilities in line with the company's patient-centric values.The role requires strong leadership experience in Quality/Regulatory/Technical areas, with a minimum of...


  • Étreux, Hauts-de-France, United States Albion Rye Associates Full time

    Albion Rye Associates is seeking a highly experienced Regulatory Affairs professional to lead our regulatory strategy and guide us through key regulatory milestones.The ideal candidate will have a strong background in FDA regulatory submissions, a comprehensive understanding of the biotechnology regulatory landscape, and an established record of working with...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    We are a patient-focused company that strives for excellence in everything we do. At Takeda Pharmaceutical, we unlock innovation and deliver transformative therapies to patients worldwide.About the RoleAs a Senior Director, Global Regulatory Lead, GI & Inflammation, you will define, develop, and lead global strategies to maximize regulatory success towards...


  • Étreux, Hauts-de-France, United States Fiducient Advisors Full time

    About the RoleFiducient Advisors, a leading investment consulting firm, is seeking an experienced Regulatory Compliance Specialist to join its team.The successful candidate will be responsible for ensuring the firm's compliance with applicable regulatory requirements, collaborating with the Compliance Manager on initiatives that drive new efficiencies, and...


  • Étreux, Hauts-de-France, United States Trebla Talent Full time

    About the RoleWe are seeking an experienced Director of Global Regulatory Strategy to lead our regulatory affairs efforts and establish a global strategy for multiple BLA programs.Company OverviewTrebla Talent is a pre-IPO, clinical-stage biotech company specializing in novel immunotherapies for cancer and autoimmune diseases. Our team is dedicated to...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...


  • Étreux, Hauts-de-France, United States State Street Corporation Full time

    About the Role:State Street Corporation is seeking a seasoned Compliance Operations Director to join its Distribution Compliance team. This dynamic role will play a pivotal part in overseeing the organization's distribution and sales practices-related control environment, building a robust second line of defense, and mentoring junior staff globally.The...


  • Étreux, Hauts-de-France, United States Meet Full time

    Job DescriptionMeet our team and explore the opportunity to support the regulatory process as a Regulatory Affairs Compliance Specialist.We are seeking an experienced professional to manage KPIs, generate reports, and collaborate cross-functionally to ensure compliance with global regulatory requirements.Responsibilities:Collaborate with regulatory teams...