Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead
Company: Agios Pharmaceuticals Inc
Posted on: April 5, 2021
Senior Manager/Associate Director, Case Management
Oversight/Medical Review Lead Location Agios Pharmaceuticals HQ Job
Code 1473 # of openings 1 Senior Manager/Associate Director, Case
Management Oversight/Medical Review Lead, Medical Safety & Risk
Management Agios (agios.com) is a biopharmaceutical company
committed to applying our scientific leadership in cellular
metabolism to transform the lives of patients with cancer and rare
genetic diseases. We are growing rapidly with an active research
and discovery pipeline across both therapeutic areas. Agios has two
approved oncology precision medicines and multiple first-in-class
investigational therapies in clinical and/or preclinical
development. Agios Pharmaceuticals is searching for a dynamic Case
Management Oversight/Medical Review Lead to join our Medical Safety
& Risk Management (MSRM) team. This position is a role that bridges
safety case management and report submissions oversight with safety
surveillance/risk management. The successful candidate will
effectively interface, cross-functionally, at all levels of the
organization as well as externally with business partners and
vendors, ensuring alignment with contractual agreements, company
policies, ICH guidelines and global regulations throughout the
product lifecycle. The individual in this role is also responsible
for providing direction and training to internal staff and
third-party vendors. The ability to work in a dynamic, changing
environment in order to meet corporate goals and patient needs is
essential. The Case Management Oversight/Medical Review Lead
reports to the Director of MSRM Case Management and serves as a
point of contact for the medical review and case processing teams,
for investigational and marketed products. The person in this
position possesses significant knowledge of case processing,
inclusive of medical review, and report submissions in order to
ensure timeliness and quality of Agios' individual case safety
reports and will be responsible to perform Quality Control review
of the vendor's work and provide feedback directly to the vendor.
The person in this position will also participate in or lead
special projects, represent MSRM Operations on Clinical Trial
Working Groups, and be an expert resource for all aspects of safety
case management and medical review to develop and support the
safety profiles of all Agios products. Key Responsibilities
- Provide input to key performance indicators (KPIs) and Key
quality indicators (KQI) for safety data processing, medical review
and safety reporting/submissions.
- Quality Control review of sample of safety cases to ensure
accuracy and quality of case processing performed by a vendor.
- Develop and administer training to medical review and case
- Medical Review Oversight
- Ensure quality and timeliness of outsourced Medical Review
activities and, when necessary, perform medical review of ICSRs
(narratives, coding, expectedness, causality and seriousness).
- Participate in safety surveillance and risk management
activities, as requested.
- Maintain reference safety information for medical review team
and demonstrate knowledge of RSI for all Agios products .
- Case Processing Oversight
- Triage drug safety inbox, identifying safety data for
processing and responding to emails requiring action or
- Provide notification and/or seek input on safety cases from
Agios clinical and medical safety representatives when
- Oversee submission of expedited ICSRs as well as distribution
of periodic safety reports to health authorities, EC/IRB, PIs and
partners, as applicable. Take urgent action to investigate
submission errors in collaboration with safety systems team to
ensure on time reporting.
- Generate MedWatch, CIOMS, and other required submission
documents for reportable cases and liaise with internal and
external personnel to ensure timely expedited reporting.
- Perform/ oversee reconciliation of safety data with data
management, business partners and vendors, as applicable.
- Collaboration with Internal and External Partners
- Communicate directly with 3 rd parties regarding processing and
timely exchange of safety data.
- Participate in cross-functional teams and contribute to/review
key clinical and regulatory documents (e.g. protocols and
associated documents, aggregate reports).
- Contribute to, maintain and implement department SOPs, Work
Instructions, tools and operational plans (e.g. Safety management
plans) owned by Agios and/or governing work performed by 3 rd party
vendors and partners.
- Participate in safety database testing and data
- Support the Quality Management System
- Identify and escalate potential compliance or quality
- Participate in/develop preventative and corrective action plans
arising from quality events, audits and inspections.
- Represent MSRM during inspections, as applicable.
- Bachelors' Degree or higher in life sciences (e.g. biology,
biochemistry, BSN, Pharmacist, M.D., or D.O.)
- Minimum 3 - 5 years of case processing experience, including
Medical Review, in the biotechnology / pharmaceutical industry
- Demonstrated ability to oversee and manage drug safety
- Experience performing/overseeing Medical Review
- Solid understanding of expedited safety reporting
- Expertise with MedDRA dictionary coding
- Expertise with software-based drug safety systems (ARGUS,
ARISg, or equivalent)
- Excellent communication and interpersonal skills including the
ability to work on teams
- Excellent written and spoken English
- Solid knowledge of ICH and global regulations for clinical
development and post-market activities pertaining to safety data
collection and reporting
- Ability to successfully prioritize and multi-task
Keywords: Agios Pharmaceuticals Inc, Cambridge , Senior Manager/Associate Director, Case Management Oversight/Medical Review Lead, Executive , Cambridge, Massachusetts
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