Cambridge, MA - Massachusetts, United States
Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.
Currently for our site in Cambridge, MA we are looking for a:
Pharmacovigilance Systems Head
This individual leads and has ownership and accountability for the maintenance including upgrades and enhancements of the Global Seqirus Pharmacovigilance Information Systems applying pharmacovigilance knowledge and software development best practices in close cooperation with vendors, IT/Egde and Quality Management Systems for a GxP environment, ensuring consistency in process and company compliance with regulatory requirements.
This position is a central coordinator and point of contact for analysis and validation of system enhancements regarding the global pharmacovigilance adverse event database, and other PV IT Systems by coordinating all SEQIRUS sites and is also acting as an interface between internal PV stakeholder, the respective IT departments, and relevant vendors.
Oversight/management of the vendor hosting the Seqirus database. Manages ongoing database enhancement and maintenance activities of the global pharmacovigilance database including coordination and prioritization with hosting vendor as needed. Serve as interface between PV business users, Seqirus IT function, Seqirus Quality functions, and hosting vendor
Manages implementation and functionality of regulatory mandated electronic transmission of Individual Case Safety Reports (E2B R2/R3), including development of business requirements and test approaches for E2B exchange with other trading partners, e.g. license partners.
Support communication and coordination between business users and vendors in data retrieval needs.
Manage developing and implementation of user requirements, database updates required by regulations, and reporting requirements defined by pharmacovigilance agreements.
Manages development and implementation of database standards and maintenance thereof (e.g. distribution matrix).
Manages the hosting vendor in support of global safety database configuration (e.g. workflow, products/licenses, studies, code lists, users) and maintain narrative and letter templates
Build with hosting vendor a compliant back-up plan and system ensuring reporting of ICSRs as per Regulatory timelines
Ensure proper uploading of the dictionaries used for AE and drugs assessment, respectively MedDRA and WHO
Oversight/management of PV IT systems in support of signal detection, risk management, literature screening, and reporting systems.
Interface with other Development functions to ensure Quality IT Systems meet PV needs (e.g. document management systems, training systems)
IT/IS/MIS degree combined with demonstrated experience and working knowledge of medical or pharmacovigilance systems/databases
Minimum of 5 years in pharmaceutical industry, thereof at least 3 years in pharmacovigilance and/or computer validation with special emphasis on the structure and software development lifecycle management of a global pharmacovigilance database.
Strong leadership skills
Sound expertise in establishment, maintenance and further improvement of global pharmacovigilance processes and systems in line with international standards and regulations
Comfort level with making independent decisions as needed in best interest of department or company
In depth knowledge of international standards and regulatory requirements/regulations related to pharmacovigilance and GCP related Pharmacovigilance
Expertise in Computer Validation
Ability to work very detail oriented, well-structured and team oriented/cross functional on a global basis
Distinct sense of legal/regulatory compliance and quality management
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.