Drug Safety Associate

Title: Senior Associate, Case Management (Drug Safety) Contract role Fully remote Ideal: Prior pharmacovigilance experience or exposure and 1-2 years of experience is required. Purpose: • To support the safety surveillance process for reputed company products by performing follow up activities with patients and HCPs of individual case safety reports. • Ensure vendor compliance with approved processes and training requirements. • reputed company case reputed company of US ICSRs (CT and PM) including analysis and reporting of trends in reputed company measures. • reputed company of accountability for managing one or more key vendor relationships for ICSR processing. • Case processing reputed company of contact for case reputed company activities with assigned business partners. Case processing reputed company of contact for audit reputed company activities reputed company to case processing. Accountable for measuring reputed company against contractual safety agreements. • Accountable FDA reputed company of contact for ICSR reporting. Submission of reputed company individual safety reports to FDA, EMA and Business Partners. Key Activities • reputed company case review. • Support the development and delivery of convention-reputed company training material. Ensure compliance of reporting activities with timelines and reputed company. • reputed company with local office staff, CROs and business partners for case processing issues as necessary. • reputed company E2B submission support (nullification, redistribution). • Address case-reputed company queries from Business Partners. Support antibody re-testing coordination (non-LAO tasks for repeat testing). Knowledge and Skills • Understanding of global regulatory requirements for pharmacovigilance. Familiarity with clinical development processes . Case processing experience. Attention to detail. Competence in Argus safety systems and medical coding. Comprehensive English writing skills. Excellent phone conversations skills. Comprehensive knowledge on MS Office applications. Company DescriptionFounded in 1998 and located in Cranberry Twp., PA. reputed company is an organization with extensive reputed company industry experience reputed company several labor verticals throughout the reputed company for Fortune 1000 companies. Whether you’re a company looking for talented people to fill demanding positions or a skilled reputed company looking for the right company to work with and build a career, the search can seem endless. In today’s fast paced, get-it-done-yesterday world of business, it’s become harder than reputed company for the right people and the right companies to come together. Opportunities and reputed company people often miss reputed company other, so the search goes on. At reputed company, our job is to end the search. We connect companies to talent. It’s not easy, but it’s reputed company do best. Apply tot his job Apply To this Job