Pharmacovigilance Physician, Associate Director: Alexion Pharmaceuticals,Inc.

Pharmacovigilance Physician, Associate Director

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About Us

Alexion is a global biopharmaceutical company that combines groundbreaking science with a steadfast commitment to meeting the needs of patients living with severe, life-threatening and often ultra-rare diseases. Alexion scientists are among the first in the world to unlock the therapeutic potential of inhibiting terminal complement, a group of proteins that play an important role in the body's immune response and can destroy healthy tissue in certain patients.

Alexion discovered and developed Soliris® (eculizumab), a first-in-class terminal complement inhibitor approved in the United States, European Union, Canada and Australia as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH). Alexion is working urgently to investigate Soliris and additional biopharmaceuticals as treatments for patients with other rare and severe diseases, including cancer.

Summary

Responsiblities:

The primary responsibilities of this position are:

• Management of individual adverse event reports from various sources
• Daily medical assessment of incoming adverse events from postmarketing sources and clinical studies
• Evaluate each adverse event report for seriousness, listedness and causality to meet regulatory reporting requirements worldwide
• Participate in regular and ad hoc case review meetings
• Maintain compliance with expedited reporting to Health Authorities
• Provide medical input for ad-hoc internal and external queries as needed.
• Contribute to IND letters to investigators for expeditable SAEs from clinical studies

• Contribute to aggregate safety reports (USPR, REMS, etc), Investigator’s Brochure and other safety-related documents
• Contribute to ongoing signal surveillance, detection and assessment
• Explore unusual index cases as appropriate
• Review data outputs on regular basis
• Track events of interest and provide overall medical assessments of these as needed
• Assist with the implementation of Risk Management Plan, REMS, survey analyses, analysis of safety data from registries for Alexion products and Investigator Brochures
• Additional responsibilities include:
• Providing medical expertise for all safety-related issues
• Providing pharmacovigilance/safety support to other functions within Alexion as needed
• Serve as a member of interdisciplinary teams as needed to support pharmacovigilance projects

Requirements

• Medical Degree (MD or international equivalent)
• Board certification in Internal Medicine and/or any of the internal medicine subspecialties preferred but not required.
• Minimum two years of safety related pharmaceutical industry experience
• Minimum two to three years of prior clinical experience (excluding internship and residency)
• Understanding of all phases of drug development (I-IV)
• Good knowledge of pharmacovigilance practices, and of US and EU pharmacovigilance regulatory requirements.
• Good oral and written communication skills
• Intercultural/intercontinental awareness to work with colleagues in other countries
• Ability to effectively listen, collaborate and cooperate with colleagues while working in a global environment
• Ability to work in a fluid/changing environment as a team player, demonstrate flexibility where appropriate and prioritize multiple tasks accordingly
• Good analytical and problem solving skills

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.

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