职位描述
职位描述:
Job Purpose:
The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products, including
single case processing, aggregate reporting, signal detection and evaluation of PV database
The Safety Scientist supports the Safety Science Leader and is responsible for a particular aspect(s) or segments of the
overall programme. The job-holder contributes to the benefit risk evaluation and to safety risk management
Primary Responsibilities and Accountabilities:
Carry out pharmacovigilance and risk management activities for specific product or products:
Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
Support the preparation and maintenance of Risk Management plans for the submission to Regulatory Authorities
Prepare and review periodic safety reports (PSUR, EU Annual Safety Reports) in accordance with regulatory
requirements and standard operating procedures
Support the preparation and maintenance of safety sections of the Company Core Data Sheet
Lead/support PDS post-marketing safety study activities
Coordinate safety activities between PDS and internal and external partners
Carry out signal detection activities and evaluation:
Conduct/support signal detection and evaluation according to SOPs and guidelines
Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines
Prepare Drug Safety reports, as necessary, for potential signals
Respond to queries relevant to the safety of Roche products from the affiliates and other internal functions
Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB)
Contribute to regulatory authority submissions (NDAs, MAA39;s, Variations) by reviewing safety data and preparing relevant sections of the submission
Participate in or provide input for Drug Safety Monitoring Boards, as necessary
Provide support to the SSL
In the case of early projects support the SSL by developing a clear understanding of the safety issues from the drug mechanism the timely medically and scientifically sound development of the clinical safety portions of a product development plan
(PDP)
Whenever assigned by the SSL, is responsible for the development and whenever appropriate the execution of RMP or REMS risk mitigation tactics.
