Title: Clinical Safety Risk Management Physician
If you are interested in the below position, please send your resume to email@example.com and reference the position title within the subject line.
Under the general direction of a Clinical Safety and Risk Management Team Lead, the CSRM Physician is an expert in drug safety and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed drugs.
––Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
––Partners with clinical development to ensure that clinical programs will support robust safety assessment of our investigational compounds.
––The CSRM physician may work closely with a cross-functional group of experts in regulatory affairs, statistics, epidemiology and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products.
––Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use
––Accountable for scientific strategy for safety related documents (e.g. CTD components, RMPs, DSUR and PADERs/PBRERs) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
––Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.
––Responsible for the development of worldwide risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.
––The CSRM physician may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.
––Works with Head of Safety to plan direction for function of the department, helps develop departmental and enterprise processes (as assigned).
Required Experience and Skills
––Minimum three (3) years clinical experience
––3-5 years of experiences in clinical safety, pharmacovigilance and/or risk management
––Must have excellent communication, writing and analytic skills
Preferred Experience and Skills
––Industry experience in both an investigational and post-marketing capacity
––Board Certification is highly desirable
––Sub-specialty in Epidemiology, or other related subspecialty preferred
––Training and/or experience in public health, epidemiology, and/or quantitative sciences
––Relevant therapeutic area experience preferred, but not required
MD/DO or equivalent