EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
PURPOSE OF THE ROLE
To establish USPS safety regulatory expertise by interpreting, communicating, and applying existing and emerging regulatory standards and requirements to shape scientific and medical safety strategies that reflect best practices and industry standards.
INTERNAL WITHIN EMD SERONO:
US Product Surveillance Medicine, US Product Surveillance Operations, Compliance Manager US Product Surveillance, Global Drug Safety Science, Chief Medical Officer, US Regulatory Affairs, EMD Serono Legal
EXTERNAL TO EMD SERONO:
FDA, Global Drug Safety, Global Regulatory Affairs, Consultants, Industry Counterparts, Industry Organizations, Global Regulatory and Scientific Policy
KEY TASKS & RESPONSIBILITIES
Ensure US and global business strategies, objectives, and processes are aligned with the existing and emerging safety regulatory environment by communicating relevant regulatory perspective to relevant internal groups (e.g. Global Regulatory Affairs, US Regulatory Affairs, GDS).
Advise colleagues on the US regulatory landscape (e.g., requirements, precedence, guidance, trends) and detailed safety-related requirements for signal detection, benefit/risk ratio, and REMS by understanding and applying FDA and global regulations.
Collaborate with the Senior Medical Director and Medical Director to interpret preclinical and clinical data and to provide recommendations on the development of the REMS for products based on current and emerging industry and regulatory trends.
Contribute expertise on the scientific application of safety regulations and draft responses to safety portion of company response to HA inquiries, audits, and inspections, including responses to FDA requests for draft guidance comments.
Provide state-of-the-art safety thinking and methodology for safety decision-making such as safety biomarkers, organ-specific toxicities, translational safety, modeling and simulation, safety biostatistics and pharmacogenetics.
Collaborate with GDS Science to enhance signal anticipation and evaluation, leading to safety decision-making earlier in clinical development with better focused target indications and populations, including opportunities for personalized healthcare.
Implement and manage formal panels of internal and/or external experts to provide cross-functional knowledge for specific regulatory or scientific topics.
Proactively engage with relevant external groups and bodies including US PV advisory boards, industry associations and the FDA, as applicable, to provide drug safety with an internal knowledge base and access to a network of safety experts.
Support business and strategic objectives by participating in industry associations, attending drug safety conferences and workshops, and authoring position papers on regulatory implications for EMD Serono’s US PV organization.
Monitor safety-related FDA regulatory changes and collaborate with global counterparts to analyze and communicate emerging regulations applicable to PV.
Understand future sources of safety information, including electronic health records, claims databases, social media etc., and incorporate these sources into our safety data acquisition and management.
EDUCATION & LANGUAGES
Science and regulatory expert with experience in drug development, clinical and post-marketing safety and Pharmacovigilance
PROFESSIONAL SKILLS & EXPERIENCE
At least 10 years of regulatory and pharmacovigilance experience
Experience leading high level project teams
Established relationships with industry experts
Expert knowledge of FDA regulations
Detailed knowledge of global regulations
PERSONAL SKILLS & COMPETENCIES
Ability to work in intense, fast paced, matrixed, multinational work environment
Strong oral and written communication skills
Ability to effectively communicate with colleagues and global counterparts
Manage multiple task s and priorities
Normal and routine office duties
Position requires both domestic and international travel up to 50% of time
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.
EMD Serono - 16 months ago
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