Senior Global Safety Associate

Senior Global Safety Associate
MON-03852

Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

Currently, we have a great opportunity for a highly motivated, seasoned professional to manage the pharmacovigilance functions and day to day activities.

Specifically, you will:

• Manage product surveillance, data review, and tabulation
• Support the preparation and coordination of periodic report including preparation of timeline, schedule, minutes, collection data from periodic report team members from other functional areas
• Collaborate with relevant department staff as guided by therapeutic lead to effectively maintain a current, detailed calendar of department-specific deliverables (e.g.; database locks, IND Annual Reports, PSRs/PSURs, etc.)
• Assist in preparation of data, agenda, minutes, schedule for safety core team and product safety committee Support the preparation of aggregate data report and ad hoc query
• Assist in development, revision and preparation of department-specific SOP’s/guidelines, work instructions and processes to ensure compliance with U.S. and international global regulations as well as with corporate policies and procedures
• Ensure all documents are maintained in accordance with established procedures and guidelines and in compliance with regulatory and Good Clinical Practices (GCP) requirements

REQUIREMENTS:

• A BA/BS in healthcare (pharmacy, nursing, or physician assistant) or life science and at least 3 years experience in the pharmaceutical, biotech, or pharmaceutical research industry, including experience with product safety processes -OR- a masters degree in health care with 2 years of related experience and/or training -OR- equivalent combination of education and experience
• The ability to interpret clinical data and provide effective summary and analysis
• Excellent organizational, detail orientation, interpersonal, team-building and written/verbal communication skills
• Working knowledge of Good Clinical Practices, Food and Drug Administration (FDA) regulatory reporting requirements, and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.

By “Challenging Science,� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.



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AMYLIN

Challenging Science. Changing Lives.