Associate Director Senior Patient Safety Scientist - Military Veterans

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u003cbu003eu003cbu003eRole: Associate Director, Senior Patient Safety Scientistu003c/bu003eu003c/bu003eu003cbru003eu003cbru003eu003cbu003eu003cbu003eLocation: Onsite Gaithersburg, MDu003c/bu003eu003c/bu003eu003cbru003eu003cbru003eAt **MEMBERS ONLY**SIGN UP NOW***., we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we do the right thing.u003cbru003eu003cbru003eThis opportunity enables you to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists play a strategic role in developing our medicines and the safety science of the program. **MEMBERS ONLY**SIGN UP NOW***.'s oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our combined experience develops as our portfolio does.u003cbru003eu003cbru003eWe are looking for an u003cbu003eAssociate Director, Senior Patient Safety (PS) Scientist u003c/bu003eto join our Patient Safety department, working in the u003cbu003eOncology Therapeutic Areau003c/bu003e. In this exciting role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your collaboration skills will facilitate cross-functional interactions with colleagues from across **MEMBERS ONLY**SIGN UP NOW***., including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.u003cbru003eu003cbru003eAs an Associate Director, Senior PS Scientist, you will be involved in aggregating, reviewing, analyzing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will apply your PV, oncology and scientific experience, knowledge and skills to deliver all aspects of safety documentation, including authoring and / or providing strategic safety input to regulatory documents, e.g., regulatory reports, health authority responses and the safety content of marketing authorization applications. If this sounds appealing to you, why wait? Apply now! u003cbru003eu003cbru003ePatient Safety sits within the Chief Medical Office, where we play a crucial role. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on outstanding performance to drive the best and most progressive drug development programs ever.u003cbru003eu003cbru003eu003cbu003eu003cbu003eEssential Requirementsu003c/bu003eu003c/bu003eu003cbru003eu003cbru003eu003culu003enu003cliu003eA Bachelor's in sciences/pharmacy/nursing degree or related field with a minimum of 3 years of experience or an advance degree with 2 plus years of relevant experienceu003c/liu003enu003cliu003ePatient Safety and/or Clinical/Drug Development proven experience working in safety u0026amp;/or scientific activities in at least 3 of the following areas:u003c/liu003enu003cliu003eClinical drug development (Early and/or Late Phase: develop u0026amp; deliver program level safety strategy, including proactive risk identification u0026amp; mitigation planning)u003c/liu003enu003cliu003ePost-Marketing Surveillance (including signal detection u0026amp; evaluation)u003c/liu003enu003cliu003eMAA/BLA submissions (preparation and authoring of the safety related aspects of the Common Technical Document)u003c/liu003enu003cliu003ePeriodic Safety Reports (deliver strategy, preparation and authoring)u003c/liu003enu003cliu003eRisk Management Plans (deliver strategy, preparation and authoring)u003c/liu003enu003cliu003eGovernance board interactions and communication across a range of activitiesu003c/liu003enu003cliu003eGood knowledge of PV regulationsu003c/liu003enu003cliu003eDemonstrated ability to handle more than one activity simultaneously, prioritizing well and recognizing key issuesu003c/liu003enu003cliu003eAbility to work effectively in an advanced matrix structureu003c/liu003enu003cliu003eFluent in written and verbal Englishu003c/liu003enu003c/ulu003eu003cbru003eu003cbru003eu003cbu003eu003cbu003ePreferred Requirementsu003c/bu003eu003c/bu003eu003cbru003eu003cbru003eu003culu003enu003cliu003eMSc/PhD/PharmD in scientific disciplineu003c/liu003enu003cliu003eUnderstanding of epidemiologyu003c/liu003enu003c/ulu003eu003cbru003eu003cbru003eu003cbu003eu003cbu003eEmployer of Choiceu003c/bu003eu003c/bu003eu003cbru003eu003cbru003e**MEMBERS ONLY**SIGN UP NOW***. embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a diverse range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.u003cbru003eu003cbru003eWe offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!u003cbru003eu003cbru003e**MEMBERS ONLY**SIGN UP NOW***. aligns with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.u003cbru003eu003cbru003e**MEMBERS ONLY**SIGN UP NOW***. embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.u003cbru003eu003cbru003e**MEMBERS ONLY**SIGN UP NOW***. requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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