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Requirements for Safety Science Contractor
Daily Activities/Responsibilities:
- Responsible for safety surveillance, signal detection and risk management activities of assigned Relay products
- Activities involve database searching, aggregate safety analysis and case level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents
- Present aggregate safety analyses review to Global Safety Lead and other cross-functional stakeholders at the Safety Management Team (SMT)
- Utilize technical skills and programs to analyze and organize data (eg, Excel pivot tables, Standard clinical TLFs)
- Serve as a project manager for SMT meetings, draft meeting minutes and facilitate approval.
- Provides pharmacovigilance functional area expertise and support to project teams for assigned developmental and/or marketed products
- Assist with / lead authoring of safety evaluations: defining scope, methodology and providing background information for aggregate safety reports; conducting preliminary safety analyses; preparing ad hoc reports including Signal Evaluation Reports and Health Authority responses
- Liaise with colleagues in relevant functional areas to gather / provide input for appropriate sections of critical documents (e.g., protocols and amendments, ICFs, IBs, CSRs, INDs/CTAs.
- Author and contribute to the PV sections of the Development Safety Update Report (DSUR)
- The Safety Scientist will partner with team members, stakeholders such as safety physicians, and study vendors or CRO partners.
- The Safety Scientist will ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate
- Develop safety report strategy with stakeholders
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $90-$110 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.
We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
Fill out the form below to get in touch with our business development team, or call us at (781) 328-1132.
The Company is an equal opportunity employer and makes employment decisions on the basis of merit. The Company prohibits unlawful discrimination on the basis of race, color, national origin, ancestry, religion, creed, age, sex, sexual orientation, gender identity, pregnancy, marital status, physical or mental disability, medical condition or any other consideration made unlawful by federal, state or local laws. The Company will also provide reasonable accommodation to the known physical or mental disability of an otherwise qualified employee or applicant. Should you need any such accommodation, please contact the Company for further information. The Company is dedicated to ensuring that all decisions regarding personnel are in accordance with all applicable laws. I certify that all statements made in this application are true to the best of my knowledge. I understand that all falsification or misleading information given in my application may result in the termination of my employment with Orbis Clinical and its subsidiaries. Furthermore, I understand that my professional conduct and clinical performance is directly related to my ability to be placed on assignments for Orbis Clinical and that I will adhere to all regulations and guidelines of Orbis Clinical. I authorization Orbis Clinical to verify the information I have provided, to contact references, and to conduct criminal, education and personal background checks concerning my qualifications, and past employment record. I understand that nothing contained in this application is intended to create an employment contract, either verbal or written, with Orbis Clinical or its clients. Furthermore, I understand that my employment, it is “at will” and Orbis Clinical or I may terminate my employment at any time with or without notice and with or without case. I acknowledge that I will be legally obligated by the terms of this document by typing my name, which will constitute my signature, or manually signing, in the provided space and electronically transmitting this document to Orbis Clinical. I agree that Orbis Clinical and I may use electronic means to conduct this transaction and that this document shall be governed and construed by the laws of the State of Massachusetts.