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The Bilingual Spanish Counselor is responsible for performing job duties in accordance with the Code of Ethics for Alcohol & Drug Counselors as outlined in the Standard Uniform California AOD Counselor Code and as outlined in the Safety Center Employee Handbook.
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Prior experience in Pre-marketing Drug Safety/Pharmacovigilance Operations. Minimum of Bachelor’s degree in Life Sciences, Healthcare, or relevant field/ equivalent qualification with 8 years of experience working in Drug Safety/Pharmacovigilance Operations.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Oversight and review of drug safety operations practices. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions.
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We are looking for an experienced, collaborative, and passionate and experienced Associate Director or Director, Drug Safety/PV. You will report to the SVP, Chief Medical Officer, support all aspects of drug safety and PV for our cell and gene therapy programs.
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Excellent understanding of the pharmaceutical industry and the future trends and developments in Drug Safety Pharmacovigilance. Clinical/medical review of SAEs, SUSARs, Analysis of Similar Events for SUSARs, as required, including reviewing the source records, reviewing the case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event "expectedness" based upon the reference safety information, preparation of sponsor assessment, and assisting drug safety staff in determining reportability.
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Executive / Senior Director, PV & Drug Safety Operations & Compliance 2007962 Location: Boston, MA (Remote) Therapeutic Areas: Undisclosed Job Overview: This job involves leadership in Drug Safety and Pharmacovigilance, building a team, providing strategic leadership in safety surveillance, and overseeing various aspects of pharmacovigilance operations.
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Authoring of the safety sections of clinical and regulatory documents, including the drug risk-benefit, safety relevant section of protocols, IB, ICF, briefing books, drug safety core information and other internal or external documents.
$275,500 - $297,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This position reports directly to the GVP Global Medical Affairs and will be evaluating, refining, updating, and growing the Drug Safety & Pharmacovigilance function at Kiniksa. A minimum of 15+ years’ experience as the Head of Drug Safety/Patient Safety/ Product Safety & Pharmacovigilance for a bio-pharmaceutical/pharmaceutical company.
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5+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug Safety/Pharmacovigilance; 3+ years in safety database management. As a Senior Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&PV) department, where you will be responsible for safety data management activities including but not limited to configurations and maintenance of safety systems, generation of complex ad-hoc reports, and implementation and validation of safety systems and solutions.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
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At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required. You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities.
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The Range Safety Officer (RSO) is accountable for executing all Range Safety Processes and as such, must be able to perform in a fast-paced, high volume environment while remaining constantly vigilant to ensure the safety of all guests and Shooters World Staff.
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Global Discovery and Development Sciences (GDDS) Boston,part of the US R&D hub, is building a new siRNA NonclinicalDevelopment department with cross-functional scientificexpertise, including toxicology, safety pharmacology, PKPD,ADME, outsourcing management, and non-clinical projectmanagement.
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Freeport-McMoRan promotes a drug/alcohol-free work environment using mandatory pre-employment drug testing and on-going drug and alcohol testing, as allowed by applicable laws. Here, you’ll find a collaborative environment where safety is a top priority, all opinions are valued, and people are empowered to grow in their career.
$22 - $30 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Strong knowledge and agility in study design and data interpretation and in the integration of Toxicology studies in the drug progression paradigm, as well as in the incorporation of safety endpoints in pharmacology studies.
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