Senior Pharmacovigilance Associate

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:? Receive, acknowledge, assess and perform data entry of post-marketing and investigational safety reports into the drug safety database and to request additional information where appropriate.? Adverse Event narrative preparation.? QC review of adverse event data entry.? Assist Operations colleagues with submission of expedited reports to Health Authorities globally. Ensure compliance with internal procedures, regulatory requirements and contractual requirements of Safety Data Exchange Agreements (SDEAs) with business partners.? Contribute to the timely preparation of ad-hoc and aggregate reports, including ICH E2C compliant Periodic Safety Update Reports, Summary Bridging Reports, US Periodic Adverse Drug Event Reports and Risk Management Plans liaising with managers, physicians and Pharmacovigilance Operations colleagues as appropriate.? Contribute to the development of clinical safety and pharmacovigilance processes within Shire and participate in training initiatives to ensure adherence/compliance.? Provision of safety data reports for safety surveillance and regular signal detection activities and ad hoc requests, liaising with Pharmacovigilance Operations colleagues as appropriate.? Assist with audit preparation.? Dealing with queries made via telephone, e-mail or face-to-face concerning general pharmacovigilance issues.? Represent PV&RM as lead contact for pharmacovigilance on project teams. Participate in multi-functional safety review teams and committees as required.? Contribute to periodic safety surveillance and signal detection activities.? Weekly review of scientific literature received from Medical Information for assigned products ? Database reconciliation and coding review.? Draft regulatory responses to specific safety concerns with marketed or investigational products? Perform safety review of protocols, informed consent forms, amendments, investigator brochures and study report reviews in collaboration with PV&RM physician as appropriate.? Provide data to support product registration and license maintenance activities.? Assist with CRO selection, budget reviews and work orders for outsourced projects? Assist with training and development of new staff and mentoring of Pharmacovigilance AssociatesShire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? Bachelor?s degree in a science or healthcare related discipline.? Experience in a medical field (R.N., medical technician, pharmacy) is preferred.? Generally has 3+ years of drug safety experience? CRA or study coordinator experience is advantageous? Must be able to demonstrate strong knowledge of global clinical safety/pharmacovigilance regulations and ICH guidelines? Previous experience of safety databases and querying/report generation? Demonstrate understanding of Quality Management processes and compliance monitoring? Requires strong attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines. ? Excellent written and oral communication skills? Good medical writing skills and ability to interpret and summarise aggregate data.? Requires experience of working with safety databases.? Working knowledge of MedDRA terminology and practices is necessary. ? Good working knowledge of MS Word, Excel, PowerPoint and Outlook.? Requires good presentation skills? Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands. ? Ability to work independently, take initiative and complete tasks to deadlines. ? Must be able to effectively present complex information to SPD management, CROs and the medical community.? Working knowledge of safety review process for IBs, protocols, informed consent and final study reports. ? Ability to respond appropriately to sensitive information and complaints.May be required to travel domestically and internationally to other Shire sites and CROs (to provide training) or to external meetings (e.g. DIA). Apply to Shire