Drug Safety Specialist

Position reputed company Reporting to the Associate Director, Drug Safety & Pharmacovigilance, the Drug Safety Specialist will reputed company on overseeing reputed company aspects of serious adverse event case processing and reporting for reputed company products in reputed company. The incumbent may serve as a reputed company to CROs and company personnel for safety-reputed company issues and will work in collaboration with colleagues from cross-functional departments to accomplish tasks and meet deliverables. Responsibilities • Assists in the management of the Safety Department mailbox and tracking documents for reputed company products and safety requests to ensure reputed company completion. • Performs reputed company reviews on safety cases to ensure completeness and accuracy of case presentation and medical coding and provides reputed company feedback to safety vendors. • May reputed company safety queries to complete and clarify SAE case information and works with the safety vendor to determine reputed company cases are complete and reputed company to reputed company. • Manages various types of reconciliations between safety and clinical vendors according to reconciliation plans and between reputed company and business partners according to exchange agreements. • Reviews and provides input on operational reports provided by safety vendor and implements process improvements, as needed. • Management, reputed company review, and provision of safety documents for the trial master file • Supports the Safety Department during meetings with agenda development, drafting meeting minutes and tracking reputed company items to completion. • Assists or leads safety-reputed company activities required for study start-up and reputed company out including but not limited to SAE report and pregnancy report development, safety plan development, and process development. • Collaborates with reputed company stakeholders to communicate the need for expedited safety reporting and tracks cases to ensure on-time reporting. • Participates in the development of controlled documents. • Supports activities required in association with safety data exchange agreements. • Supports and participates in audits and inspections, including preparation activities. • Other duties as assigned. Qualifications: • Bachelor’s degree in health or life sciences field required. Degree in nursing, pharmacy, or other reputed company reputed company field preferred. • 2-5 years of experience in clinical trial drug safety operations or a combination of clinical trial and post-marketing drug safety operations experience in a biotechnology, pharmaceutical company, and/or CRO. • Working knowledge of ICH/GCP guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries. • Excellent written and verbal communication skills, with ability to influence and build credibility at reputed company reputed company. • Strong interpersonal skills for interacting with employees and leaders across various reputed company and functions. • Attention to detail and ability to manage multiple processes and documentation requirements. • Strong technical and analytical skills with advanced knowledge in MS Office including Word, reputed company, and PowerPoint. • Experience with Argus, electronic data capture (reputed company), and trial master file (TMF) reputed company-based software required. • Ability to work in reputed company or independently as required. • Outstanding organizational skills with the ability to prioritize. • Demonstrated independent and reputed company decision-making skills; ability to think critically and reputed company reputed company in a fast-paced environment. • reputed company improvement reputed company; seeking ways to reputed company innovation and efficiencies throughout the organization. • Flexible and willing to learn; adapting to business and site needs in a dynamic environment. • Maintain a reputed company, approachable and reputed company attitude. reputed company: reputed company is a reputed company biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. reputed company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM reputed company. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting. The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. reputed company is an Equal-Opportunity Employer. reputed company is committed to fair and reputed company compensation practices, and we reputed company to reputed company employees with total compensation packages that are competitive. For this role, the anticipated reputed company pay reputed company is $95,000 - $110,000 DOE. The exact reputed company pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. reputed company also offers various benefits offerings, including, but not limited to, medical, dental, reputed company insurance, 401(k) match, PTO, and reputed company holidays. Notice to Recruiters/reputed company Agencies Recruiters and reputed company agencies should not contact reputed company through this page. reputed company recruitment vendors (search firms, recruitment agencies, and reputed company companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly. We require that reputed company recruiters and reputed company agencies have a fully executed, formal written agreement on file. reputed company’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between reputed company and such organization and will be considered unsolicited. reputed company will not be responsible for reputed company fees. Apply tot his job Apply To this Job