Medical Safety & Risk Management (MSRM) is responsible for managing the safety profile of products throughout their lifecycle through the continuous monitoring, assessment and communication of safety information. As such, MSRM plays a key role in the management of emerging safety signals in drug development and for maintaining this activity for products in the post-marketing setting. MSRM also ensures on -time reporting of high quality individual case reports and as well as the creation and timely submission of aggregate safety reports to fulfil global regulatory requirements. In addition, MSRM is an active participant in the creation of clear, consistent, and accurate product labelling and other product-related information.
Fellowship Goals and Objectives
The goal of the Agios MSRM Fellowship Program is to give the fellow hands-on knowledge of US and global pharmacovigilance activities including a broad understanding of pharmacovigilance operations, signal detection, and risk management across all stages of drug development from early stage to post marketing and to gain a broad understanding of pharmacovigilance operations.
Developing a strong safety risk management knowledge base and applying those skills practically in the arenas of signal detection and signal management
Obtaining well-rounded knowledge of country-specific pharmacovigilance regulations
Cultivating strong communications and project management skills
Collaborating cross-functionally with various departments within the company as a partner in the product development process
Agios is a biopharmaceutical company passionately committed to applying scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Agios has a dynamic culture, which supports our employees’ unwavering commitment to science and patients. World-class founding and leadership teams with the experience and track record to provide the insights required to develop groundbreaking medicines lead a group of exceptional employees. We pride ourselves on fostering an interconnected environment that encourages creative scientific collaboration across disciplines. Our unique culture, combined with the commitment and passion of our team, reflect our belief in an “other side of possible” approach to our challenges and our work.
For more information or questions, please contact:
To be considered for an interview at Midyear, please register for both ASHP Midyear and PPS and then complete a fellowship application on the MCPHS Fluid Review application portal. Visit https://mcphs.fluidreview.com/
Please DO NOT request an interview within PPS. Our recruitment teams will contact qualified candidates via PPS to schedule interviews.
Before ASHP Midyear Clinical Meeting
Applicants must upload the following application materials to the online portal prior to November 26, 2018:
Letter of intent
Unofficial college transcript
Contact information of three references for letters of recommendation.
Incomplete applications WILL NOT be reviewed. ASHP Clinical Midyear Meeting interviews CANNOT be scheduled until these materials have been submitted. Please keep in mind that this is a competitive process and applicants are encouraged to complete their applications as soon as possible.
After ASHP Midyear Clinical Meeting
The three letters of recommendation must be submitted by the three provided contacts no later than December 10th
Top candidates will be invited for onsite interviews at the sponsoring company’s location. Final candidates will be required to go through additional screening / onboarding as required by MCPHS University.
The MCPHS Biopharmaceutical Industry fellows will be selected on a nationally competitive basis, with interviews at the American Society of Health Systems Pharmacists (ASHP) Midyear meeting.
Applicants must have a Doctor of Pharmacy degree from an ACPE accredited college of pharmacy at the commencement of the program.
Candidates must have strong written and verbal communication skills and a strong interest in pursuing a career within the biopharmaceutical industry.
All candidates must have authorization to work in the United States throughout the duration of the one or two-year fellowship. No visa sponsorship will be provided.
Additional Salary Information: Fellows will receive a competitive stipend and benefit package, including comprehensive health insurance.
About MCPHS University / Agios Pharmaceuticals
Agios is a biopharmaceutical company passionately committed to applying our scientific leadership in the field of cellular metabolism to transform the lives of patients with cancer and rare genetic disorders. Metabolism is a complex biological process involving the uptake and assimilation of nutrients in cells to produce energy and facilitate many of the processes required for cellular division and growth. We believe that dysregulation of normal cellular metabolism plays a crucial role in many genetic diseases. We believe Agios is a first mover in using cellular metabolism, an unexploited area of biological research with disruptive potential, as a platform for developing potentially transformative medicines. We intend to apply our deep understanding of metabolism, coupled with our ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and rare genetic disorders are treated.
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