Associate Director, Signal Management and Innovation Seeking an Associate Director, Signal Management and Innovation to ensure signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences).Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (eg with Global Regulatory Affairs, Data Sciences).Ensures that Signal Management processes and activities are compliant with Global Health Authority expectations, including EU regulations and EU regulatory authority and inspectors' expectations. Represents Pharmacovigilance and externally at a global level as an authoritative expert on signal detection processes. Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained. Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose. Leads interactions and oversight of signal management activities conducted by any vendor. Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders. Leads interactions with other relevant functional areas both within and outside of GPSE to ensure standards are maintained. Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required. Designs and delivers relevant training as appropriate. Provides mentorship and guidance for junior/new pharmacovigilance scientists and others as appropriate. Conduct project activities for designated processes. Any other tasks assigned by manager to assist in related departmental activities. Health care background or life science degree/Bachelors required; degree in life sciences preferred. Excellent document creation skills. In depth knowledge and experience of clinical trial methodology, pharmacovigilance regulations, signal detection and risk/benefit analysis. Critical, strategic thinking and decision-making skills. Ability to review, analyze, interpret and present complex data to a high standard. Global player in a PV organization with the ability to adapt to change. Excellent communication and presentation skills. Good level of computer literacy. Excellent organization skills and ability to prioritize. Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins. Synectics is an equal opportunity employer.
