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Drug Safety and Pharmacovigilance Operations Intern

Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: March 17, 2019

Job Description:

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer. More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer. Pharmacyclics is seeking for a summer intern to work in Drug Safety and Pharmacovigilance Operations The Internship: Some see it as public health, some see it as risk/benefit management, and others see it as drug safety. All would agree safety is a cornerstone of the drug approval process, and crucial to prescribers informed decisions as well as the patients' lives. At Pharmacyclics within the department of Drug Safety, Pharmacovigilance and Epidemiology (DSP&E), Drug Safety and Pharmacovigilance (DSP) Operations team is responsible for the case management of clinical trials and post marketing reports. Oversight of submissions to the Principal Investigators, Ethic Committees and worldwide regulatory authorities. Additionally, PV Quality and compliance function within the DSP is responsible for monitoring the quality of safety activities, vendor management, and compliance to regulations and contractual agreements. This summer internship program offers first-hand experience and meaningful contributions to core functions within DSP Operations as well as broader exposure to various roles within the industry. The intern will learn fundamental principle of DSP operations and will get exposure and interaction in a team-based work environment at a pharmaceutical/ industrial setting. Will gain core knowledge of industry regulations (ICH, FDA, GCP, GvP). Familiarity with common Safety database (e.g. Argus, etc.). Exposed to collaborations with the internal team members, and external partners. Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding. Broader growth and development are offered by the internship program through networking opportunities, career development discussions, etc. Requirements: -- Complete at least second year of university studies prior to internship start date with major in a health professional degree program including biological of Science, Public Health, and other relevant fields -- Currently enrolled and in good standing at a US accredited college/university -- Maintain a minimum cumulative GPA above 3.0 or equivalent -- Desire to learn about drug safety in the field during drug development and throughout the product life cycle -- Work collaboratively in a team-based environment to support ongoing scientific deliverables -- Ability to complete 10 weeks of internship work, starting either June 10 or June 24 Job description: Under the oversight of DSP Operations: This individual will be responsible for collection, preparation, and reporting of serious adverse events for Pharmacyclics sponsored trials and programs. Additionally, will be involved with study and vendor management, cross functional collaborations, and quality and compliance monitoring activities. Preferred Knowledge, Skills, and Abilities:

  • Self-motivated, excellent organization and planning skills
  • Scientific and medical terminology acumen
  • Strong interpersonal skills and communication skills (both written and oral)
  • Proficiency in Microsoft Office Suite
  • Strong commitment to compliance with the relevant rules and procedures Final Presentation: Each Intern is expected to prepare a short presentation to their team to share what they have learned through their internship and how they hope their experience will help in their future career pursuit. Presentations may be approximately 10-15 minutes long and should include visual aid (posters or PowerPoint) Equal Opportunity Employer Minorities/Women/Veterans/Disabled

    Keywords: Pharmacyclics, LLC, Sunnyvale , Drug Safety and Pharmacovigilance Operations Intern, Other , Sunnyvale, California

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