Senior Manager, Medical Safety and Risk Management Operations
The Medical Safety and Risk Management (MSRM) Operations Sr Manager position is a unique role, bridging Case Management and Safety Database Systems. This individual must effectively interface cross-functionally at all levels of the organization as well as externally with vendors and regulatory authorities, ensuring alignment with internal processes, company policies, ICH guidelines and global regulations.
The MSRM Operations Sr Manager reports to the Senior Director of MSRM Case Management, and works closely with the Safety Systems Lead to ensure business requirements for product safety assessments and reporting are supported by the System. The candidate will be responsible for developing standards and processes with an emphasis on global compliance for both investigational and marketed products, and is also responsible for providing direction and training to internal staff and third-party vendors. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
The person in this role is responsible for managing pharmacovigilance operations requirements for development and approved products in an efficient and effective manner. A key aspect of this role is cross-functional collaboration and external benchmarking to support accurate safety data processing and reporting to regulatory agencies.
Contribute to MSRM quality management and compliance plans.
Support and contribute to controlled documents and associated instructions.
Identify and collaborate to correct potential compliance issues; participate in preventative and corrective action plans arising from audits and inspections.
Support and/or provide vendor oversight
Communicate with partner companies, vendors, and internal groups regarding processing and timely exchange of safety data
Represent MSRM Operations on cross-functional teams and contribute to the generation and review of key clinical and regulatory documents (e.g. protocols and associated documents, aggregate reports)
Maintain current knowledge of relevant regulations for safety data collection and individual safety case reporting
Contribute to and/or develop, maintain and implement:
Controlled documents (SOPs), data conventions/guidelines and other process documents
Operational plans between Agios and 3rd party vendors and partners
Safety Management Plans for study specific workflow between Agios and CRO(s)
Tools and processes for database requirements and configurations to enable safety-related activities during studies
Training requirements and materials for internal and vendor activities
Key performance indicators (KPIs) for safety data processing and reporting
In collaboration with Safety Database Systems:
Ensure alignment between Safety System requirements and vendor/partner agreements
Develop queries and reports for periodic or ad-hoc data requests
Ensure data quality by overseeing or performing quality checks
Implement enhancements and maintain validation of safety system
Assist with oversight of hosting vendor and business partner projects
Life Sciences professional with, at minimum, 5 years of clinical or research experience; training in pharmacology, epidemiology or regulatory science is a plus.
4+ years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry
Ability to oversee and manage drug safety vendors
Knowledge of MedDRA dictionary
Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
Strong computer skills (MS Office)
Excellent communication and interpersonal skills, including ability to work effectively and cross-functionally
Excellent written and spoken English
Solid knowledge of ICH and global regulations pertaining to safety data collection and reporting
Ability to successfully prioritize and multi-task
Experience generating reports using reporting tools (Cognos, OBIEE, etc)
Experience using analytics tools (Spotfire, Tableau, etc)
Experience with UAT (User Acceptance Testing) in Oracle Argus Safety System
Problem Solving Uses logic and methods to trouble shoot and propose effective solutions
Perspective Has a broad view of issues/challenges; thinks globally; considers near-term and future issue impacts; weighs risks and potential gains
Drives and Delivers : Executes and Operates to a High Standard and Resourceful
Connect and Relate : Collaborates and Talks Straight
Build and Transform : Improves Continuously and Builds Networks
Lead from Every Chairs : Empowers Self and Others and Challenges Self and Others