This role is considered Hybrid.
Overview This position develops, implements, and oversees processes and procedures for clinical trial ICSR processing activities, including oversight of the case processing outsourced service provider(s).
The incumbent will work in close collaboration with pharmacovigilance physicians and cross-functional team members on operational safety issues.
This individual will ensure that vendors are following relevant safety management plans and providing high quality ICSRs, through collection and analysis of KPIs.
This individual will ensure compliance and adherence to Alnylam pharmacovigilance processes and global regulatory requirements.
Summary of Key Responsibilities Provide pharmacovigilance operations leadership and guidance to cross-functional teams for Alnylam's clinical development programs, serving as the subject matter expert on regulations and best practices for handling safety data in Alnylam's global safety database.
Responsible for development and maintenance of Safety Management Plans for Alnylam clinical trials Provide expert safety input and review of study specific documents (e.g., protocols, IBs, Pharmacy Manuals) Collaborate with Global Safety Systems team to support configuration of study specific requirements and reporting rules.
Proactively identify process gaps and implement mitigations to ensure compliance with GCP and GVP regulations and study-specific protocols.
Provide direction and leadership for clinical trial case processing activities to outsourced service provider(s) Develop Clinical Trial PV training materials to support new and existing projects.
Develop and refine controlled documents and tools, in collaboration with cross functional teams, CROs and vendors to execute best pharmacovigilance practices and maintain regulatory compliance.
Works with the Quality organization for audit and inspection preparedness and supports GPSRM during regulatory inspections and audits.
Oversees completion of SAE reconciliation activities end end-of-study unblinding, in accordance with study timelines.
Assist in conducting training to new team members and less experienced Global Safety Operations team members.
Act as Global Safety Operations functional representative on cross functional projects Qualifications Alnylam prides itself on its entrepreneurial, fast-paced environment where success is rapidly rewarded.
There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth.
This position offers an opportunity to have tremendous impact on the growth of the company.
The culture values hard-work, creativity, flexibility, a sense of humor and a hands-on, problem-solving attitude.
The ideal candidate will have the following mix of personal and professional characteristics:
University degree in biological or natural science or health care discipline required.
Minimum of eight years relevant experience in Patient Safety activities in pharmaceutical industry Demonstrated ability to understand, interpret, analyze, and clearly present scientific and medical data in verbal and written format.
Solid understanding of systems and reporting tools utilized to support pharmacovigilance activities.
Demonstrated ability to be highly collaborative and effective in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, Biostatistics and Regulatory), as well as with external colleagues for partnered products.
Demonstrated ability to lead and mentor personnel.
Ability to work independently, with minimal supervision.
Excellent written and verbal communication skills Solid experience in drug development process Solid understanding of applicable global clinical trial safety regulations and post marketing regulations and experience in participation in regulatory inspections/audits Strong organizational skills Experience with overseeing and coordinating work with external vendors.
Ability to comply with Global regulatory requirements (i.e., ICH, GVP, FDA, MHRA, EMA) About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases.
Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease.
Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make.
Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world.
Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity.
We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.
By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
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