Roche Hiring Medical Information Services Partner
The Position
Ensuring that all enquiries related to designated Roche products received from all sources e.g. via phone; e-mail; letter; fax; face to face are dealt with to the required standard. ● Channeling non-MI to relevant functions (Pharmaco-Vigilance, Supply Chain, Quality, …).
● Providing scientific, balanced and up to date Medical Information on Roche products to external and internal customers. ● Responding to unsolicited enquiries from customers on Roche products, including both on and off-label enquiries.
● To ensure logging and tracking of all queries in the applicable medical
computerized system, in line with Roche Policy as well as local laws and
regulations.
● Escalating MI2 enquiries as per Regional Hub model and sending the final answer to customers.
● Ensuring responses are timely, meeting local requirements
● Developing knowledge on allocated products and maintain a current understanding
on new developments in assigned therapy area(s).
● Developing Affiliate Standard Responses if needed at local level. Uploading and
maintaining these in applicable medical computerized system
● Providing MI Insights to local medical teams in order to contribute to medical
strategy and planning activities
● Providing inputs to Regional and Global MI initiatives, if needed.
● Performing Quality monitoring activities as per MI minimum standards business
processes
● Recognizing and documenting non-Medical Information enquiries and triage the Information to the appropriate internal function.
Added Value Medical Services:
Developing and implementing the strategy for delivering added value medical information services to internal stakeholders and external customers (congress information sharing, literature searches, …), in close collaboration with the Medical Information Global community and in co-creation with customers
Compliance:
● Identifying, collecting and reporting any AE and/or other reportable event and forward to drug safety department within timelines described in relevant SOPs
● Identifying and reporting any product quality complaint and forward to local Complaint manager within timelines described in relevant SOPs.
● Monitoring MI intake channels and pre-cases/cases in the applicable MI inquiry handling system at least once each business day
● Participating in the reconciliation process of AEs in collaboration with the LSR
● Participating in the reconciliation process of PCs in collaboration with the Local Complaint Manager
● Participating in the Quality Check (QC) of all information in the MI inquiry in order to identify any missed AE reports (shared responsibility between the Local MI Responsible and the Local Safety Responsible)
● Assuring compliance with Roche Global and Local MI Directives/SOPs and Local regulations.
● Writing or contributing to local SOPs/work instructions for MI processes if applicable
● Ensuring integrity and scientific accuracy of the MI responses. (If acting as MI Accountable*: performing the MI Accountable responsibilities described in the Medical Information Minimum Standards XBP-0100019.)
● Copyright clearance for each article provided to the customer.
● Providing training for the business units, sales force, medical department and other roles in the affiliate on medical information processes to ensure Compliant and high quality customer service.