Travel Required: Less than 10% Public Trust: NACI (T1) Requisition Type: Regular
GDIT is seeking an experienced Pharmacovigilance Physician (PVP) in support of the U.S. Army. This individual 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 safety pharmacovigilance expert.
In this role, the PVP will:
- Serve as the safety pharmacovigilance expert and sponsor protocol review board chairperson and act as the lead medical officer. As the medical officer, the employee shall advise on medical issues, and represent the Division as the sponsor medical expert for FDA regulated clinical trials.
- Provide pharmacovigilance and benefit risk assessments of The Surgeon General (TSG) sponsored products throughout the product lifecycle. The PVP shall assist/support the Integrated Product Team and Product Safety Surveillance Branch (PSSB) with all aspects of developing the product safety profile, for the development and marketing of FDA- regulated medical products. The employee 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.
- 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.
- Provide documented ongoing safety surveillance and safety analysis of TSG-sponsored medical products and coordinate reviews with the PSSB in order to ensure compliance with regulatory requirements.
- 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 employee 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 shall assist in drafting/updating and/or reviewing the safety section of the Investigator’s Brochure.
- 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 shall attend sponsor meetings to convey safety related medical information.
- Over 5+ years experience in regulatory compliance.
- Experience with working regulatory actions with the FDA
- Must be a U.S. Citizen
- Must be Public Trust clearable
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.