Shire PV Submissions Manager in Cambridge, Massachusetts
Primary responsibility is to oversee the quality of Individual Case Safety Report (ICSR) submissions to regulatory agency and licensed business partners and to ensure compliance with Safety Data Exchange Agreements (SDEAs) and regulatory reporting requirements. The incumbent is responsible to ensure that the quality of ICSR data elements transmitted to regulatory authorities meets company standards and global reporting requirements. The Pharmacovigilance Submissions Manager is also responsible to ensure that changes to the Shire Global Safety System (SGSS) reporting rules are aligned with local requirements and to assess the impact of these changes across all Shire products.
Job Function and Description
- Monitor ICSR timelines to ensure that submissions to regulatory agencies, business partners, and contract research organizations (CROs) are compliant with regulatory requirements and SDEAs
Assess impact of new regulations and SDEAs on the safety database reporting rules and oversee updates as appropriate
Lead algorithm review activities to ensure complete and accurate product, license, and reporting rules are configured in SGSS in accordance with Shire procedures
- Track quality of ICSR submissions to ensure that data elements meet established standards. In conjunction with Manager, PV Data Quality, identify and implement quality improvements
- Support GDS Quality, Standards and Training in the identification of root causes for late ICSR submissions, and the implementation of appropriate corrective actions
- Identify and support implementation of new SGSS functionality to improve quality and timeliness of ICSR submissions
Education and Experience Requirements
Bachelor’s degree in a science or healthcare related field is required.
At least 5 years of drug safety experience in a pharmaceutical company with experience in AE case processing and ICSR submissions.
Strong knowledge of clinical and post-marketing global regulatory reporting requirements for drugs and biologics required; additional knowledge of global reporting requirements for devices desirable.
Experience with safety databases (ICSR submissions, data entry, and report generation).
Key Skills, Abilities, and Competencies
Experience working with quality management processes and compliance monitoring
Strong attention to detail in composing and proofing-reading materials, establishing priorities, scheduling and meeting deadlines.
Demonstrated ability to work in a fast paced environment and simultaneously manage multiple competing tasks and demands.
Ability to work independently, take initiative and complete tasks to deadlines.
Ability to independently resolve problems and conflicts.
Decision-making capability, providing advice to the team.
Good interpersonal, communication, analytical and organisational skills.
Demonstrated ability to work on cross-functional teams and manage to project timelines.
Complexity and Problem Solving
Decisions relating to interpretation of regulatory reporting requirement on submissions of ICSRs globally.
The Pharmacovigilance Submissions Manager must have a good understanding of those decisions that need to be referred to senior managers. The impact of potential problems may be highly complex and involve active communication in a cross-functional setting to manage various aspects of determining the optimal solution.
The Pharmacovigilance Submissions Manager will assess and make recommendations for enhancements for current processes and SOPs to ensure that they are suitable and conform to best practice.
Systems aspects of the role require comprehensive understanding of how ICSR reporting rules function in the SGSS and will make recommendations for enhancements, provide user requirements and participation in database upgrades.
Mentor best practice for ICSR submissions and advise on the application of existing SOPs and guidelines. Regularly interact with Regulatory staff to meet local ICSR reporting requirements.
Other Job Requirements
Domestic and international travel will be required (<20%).
May be required to travel domestically and internationally to other Shire sites and CROs to provide training or to external meetings. Driver’s license optional but preferred.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.