SoBran Inc. is currently seeking a Safety Pharmacovigilance Physician – Medical Officer (proposed effort) to join our team in Maryland.
- Serve as the Sponsor’s safety pharmacovigilance expert
- 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, 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 TSG-sponsored products throughout the product lifecycle.
- 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.
- 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 client 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, 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.
- 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.
- Attend sponsor protocol review board meetings, as required.
- Attend sponsor meetings to convey safety related medical information.
- Be available as needed, 7 days a week, in the event of an emergency.
Must be a licensed physician (MD) with clinical practice and clinical research/drug safety experience. Must have experience with writing pharmaceutical or health-related documents and significant clinical trial experience. Must have highly skilled expertise and detailed working knowledge of FDA regulated medical safety/Pharmacovigilance and FDA regulated strategic thinking.
SoBran, Inc. is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability, protected veteran or other status protected by federal, state, and local laws.