To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- PVG physician support shall utilize highly skilled expertise and detailed working knowledge of FDA regulated medical safety/Pharmacovigilance, FDA regulated strategic thinking, and leadership to serve as the Sponsor’s safety pharmacovigilance expert. The Contractor shall also serve as the sponsor protocol review board chairperson and act as the lead medical officer in support of the Division Director. As the medical officer, the Contractor shall advise on medical issues, and represent the Division as the sponsor medical expert for FDA regulated clinical trials.
- The PVP shall provide pharmacovigilance and benefit risk assessments of TSG-sponsored products throughout the product lifecycle. The PVP Contractor shall assist/support the IPT and staff in PSSB for all TSG-sponsored products with all aspects of developing the product safety profile, for the development and marketing of FDA-regulated medical products. The PVP Contractor shall ensure that the safety surveillance and benefit risk management activities are consistent with FDA/ICH, Army/DOD operating processes, procedures, regulatory and legislative requirements.
- The PVP Contractor shall assist the PSSB branch with any and all safety related requirements for medical and scientific support, including but not limited to, providing written regulatory assessments of serious adverse events reported to the Sponsor including severity and causality assessments, expedited reporting determination, and analyses of similar events preparation.
- The PVP Contractor shall provide documented ongoing safety surveillance and safety analysis of TSG-sponsored medical products and coordinate reviews with USAMMDA PSSB in order to ensure compliance with regulatory requirements.
- The PVP Contractor shall identify and manage evolving safety concerns with products by utilizing signal detection tools and proactively implementing risk management initiatives in accordance with global regulatory requirements.
- As part of the medical safety evaluation, the PVP Contractor shall provide written initial and follow-up review of clinical protocols, review of clinical protocol-associated safety documents and agreements with partners (e.g. safety management plans, safety review committee charters, safety data exchange agreements, others), review of safety data in FDA-regulated documents such as study reports and annual reports, participation in external audits from partners or regulatory authorities, and serve as subject matter expert on DSMBs or DMCs. The PVP Contractor shall assist in drafting/updating and/or reviewing the safety section of the Investigator’s Brochure.
- The PVP Contractor shall provide medical and scientific expertise on pharmacovigilance matters and shall attend Integrated Product Team or working group meetings to discuss safety concerns of the team with the protocol and protocol related documents. The safety physician shall attend sponsor protocol review board meetings, as required. The PVP Contractor shall attend sponsor meetings to convey safety related medical information.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.