Drug Safety Associate
Posted: 5 days ago
Job Description
A career at Pfizer offers opportunity, ownership, and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.Reports to Country Safety Lead and will primarily be responsible for the submission of individual and, where appropriate, aggregate safety reports. Other activities can include review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer’s products and to meet regulatory requirements.Main responsibilities include:Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliationDevelop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety databaseDetermine reportability of scheduled reports, ensuring adherence to regulatory requirementsConsistently apply regulatory requirements and Pfizer policiesParticipate, as appropriate, in local, internal and external safety activitiesIn order for you to be successful in this role you will have some (or most) of the following:QualificationsHealth Care Professional or equivalent qualificationTechnical Requirements (Minimum Requirements):Strong analytical skills with the ability to interpret complex dataDemonstrated computer literacySolid understanding of medical terminologyExcellent written and verbal communication skillsFluency in spoken and written English Fluency in spoken and written ChineseAbility to work collaboratively in a team environmentAbility to make basic decisions with an understanding of the consequencesPreferred Requirements (i.e., preferred education, experience, attributes):Basic understanding of regulatory requirements and corporate policiesExperience in pharmacovigilance or drug safetyExperience in pharmacovigilance and/or data management preferred but not requiredExperience and skill with medical writing an advantageAbility, with supervision, to solve routine problems and to surface issues constructivelyAbility to achieve personal objectives while meeting departmental standards of performanceAbility to work under supervision in a matrix organizationIf you are looking for a unique opportunity to join a true global leader in a role that will enable you to provide key contributions to the company’s growth this is the role for you.Work Location Assignment: HybridAt Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:Paid parental leaveAccess to Health & Wellness appsCareer Growth Experiences programRecognition & rewards programPaid volunteer daysLife Insurance BenefitsPfizer Learning Academy access to top content providersAccess to flu vaccines & skin checksOptions to purchase additional leaveSalary packaging & novated lease optionsBenefits listed may vary depending on your position and location and may be subject to change. Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.Medical
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