Pharmacovigilance & Risk Management Writing Director

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:Reporting to the Senior Director, Pharmacovigilance, the Director, Pharmacovigilance & Risk Management Report Writing will be responsible for medical writing, management of reference documentation, training and quality control associated with aggregate report writing in pharmacovigilance. Activities include the preparation and expert oversight in the preparation of company Periodic Safety Update Reports, Risk Management Plans, responses to regulatory enquiries and ad hoc safety reports.?Support the PV&RM therapeutic area teams in the preparation and updating of Risk Management Plans; maintain archiving and version control of RMPs. ?Provide expert oversight and quality control in the preparation of aggregate reports in liaison with the therapeutic area-specific Pharmacovigilance Associates and Physicians accountable for their authorship. These include periodic safety reports (e.g. PSURs, EU Annual Safety Reports) and ad hoc reports for Shire marketed products (e.g. review of a potential signal, response to a health authority safety query, EU Type II variation, US Changes Being Effected). Report review, revision and editing will be part of these responsibilities.?Training and mentoring for the Global Pharmacovigilance and Risk Management Department in medical writing skills and best practices in association with aggregate report preparation.?Liaise with PV&RM Operations, Quality and Standards group to develop and maintain associated processes within Shire, identifying areas for process improvement as required. ?Represent PV & RM Department in cross-department task forces and establish processes and relationships with other functional areas to ensure needs of PV & RM are met.?Provide necessary support to the EU Qualified Person for Pharmacovigilance.Shire 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: ?Life Science Degree or healthcare professional.?Post-graduate qualification (PhD, PharmD) in a relevant discipline preferred.?Minimum of 5 years previous experience working in a similar role with direct experience of aggregate report preparation (PSURs, ASRs, Integrated Summaries of Safety, etc).?Ability to summarise aggregate safety data and identify the key areas for focus in reports.Experience should include:?Excellent English medical writing skills gained through a demonstrable record of accomplishment.?High level of expertise and experience in the preparation of aggregate safety reports and the ability to summarise aggregate data in a clear and concise manner and define key messages.?Attention to detail and experience in quality control of aggregate reports.?Previous experience of SOP development and the development of training materials is desirable.?Solid understanding of the regulations supporting aggregate regulatory reports including ICH guidance, FDA regulations, the E.U. Clinical Trial Directive and Volume 9a.?Strong mentoring and interpersonal skills and experience in training others in medical writing.?Self-starter with ability to prioritize, multi-task and work in a matrixed organization.Up to 10% travel may be required. Will be required to travel domestically and internationally to other Shire sites and CROs or to external meetings (e.g. DIA). Apply to Shire