Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and …
Skills: Pharmacovigilance, Medical Regulatory Support, Adverse Event Reporting, Safety Surveillance, Data Safety Monitoring Boards
Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and …
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Job DetailsJob Location: Bethesda MD - Bethesda, MD 20817Position Type: Full TimeSalary Range: $85,000.00 - $92,000.00 Salary/yearJob Category: Health CareJoin a Team Dedicated to Patient Recovery and Growth Phoenix Phys…
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U.S. Renal Care
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Global Solutions Network, Inc.
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Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and …
About the Position The Regulatory Compliance Coordinator prepares, submits and maintains regulatory documents related to research; serves as principal administration liaison for projects; develops and maintains recordkee…
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Full-time
postgraduate degree
Posted 15d ago
~40 hrs/week
Responsibilities
The Pharmacovigilance Physician provides medical regulatory support for the detection, evaluation, and prevention of adverse reactions to investigational products. Responsibilities include managing safety cases, developing safety surveillance plans, and coordinating Data Safety Monitoring Board activities.
Requirements
Candidates must hold a US license and be a US citizen or a full Green Card holder. The role requires expertise in pharmacovigilance, regulatory reporting, and the ability to manage safety data in compliance with FDA and ICH guidelines.
Full job description
Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
Title: Pharmacovigilance Physician (FTE)
Location: Fredrick, MD (Hybrid- two days a week on-site)
Requirement: US License
Responsibilities:
The individual shall provide medical regulatory support for activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to investigational products. Pharmacovigilance support includes but is not limited to the following:
-Provide continuous pharmacovigilance support to receive, assess, and escalate adverse event reports IAW regulatory timelines and sponsor SOPs including intake, triage, assessment, and reporting of adverse events, ensuring 24 hours per day, 7 days per week coverage, including holidays and weekends.
-Develop pre-market and post market safety plans.
-Surveillance plan(s) specific to products/protocols that include signal detection tools and templates necessary to implement the safety surveillance
-Develop and maintain safety management plan(s) that delineate the roles, responsibilities, processes, and timelines for safety activities and drives the execution of the safety related activities during a trial
-Establish Data Safety Monitoring Boards (DSMB)/Committees, which includes identifying members, developing, reviewing and finalizing the initial Charter and any revisions
-Schedule and coordinate DSMB/Committee Meetings (organizational, in-process, executive, and ad hoc), including a face-to-face initial DSMB/committee organizational meeting at a central location within the continental United States, and provide an agenda.
-Develop and prepare written DSMB meeting minutes for each meeting per SOPs
-Provide the DSMB/Committee Chair Recommendation(s) form, completed and signed by the DSMB/Committee Chair within 24 hours of the meeting conclusion, documenting the DSMB/Committee decisions and recommendations to the Safety Office
-Provide pharmacovigilance support that includes but is not limited to reviewing clinical protocols and associated documents, conducting literature searches, providing risk-benefit analyses, developing comprehensive risk mitigation plans, and writing white papers
-Provide pharmacovigilance guidance and subject matter expertise
-Receive, process, evaluate, and manage reported safety cases through electronic systems, such as Argus, which may include but are not limited to data entry and preparation of serious adverse event narratives, generating analyses of similar events, data element coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities and preforming quality control reviews of the entered data
-Monitor the safety mailbox at a minimum twice a day 7 days a week, to include weekends and holidays, for new incoming unexpected and related serious adverse events
-Triage safety reports, interpret clinical data, and perform regulatory evaluation for regulatory reporting purposes
-Track follow-up information /correspondence through to case closure
-Report serious adverse events to the FDA and other applicable regulatory authorities IAW 21 CFR 312.32 and 312.33, and ICH Guidelines
-Identify database cases eligible for archiving and assist with archiving all documents in compliance with government internal standards and regulatory guidelines
-Provide strategic input or oversight for regulatory documents including, but not limited to, Investigational New Drug application safety reports (MedWatch), annual reports, and final clinical study reports
-Notify the investigator(s) of safety information, including expedited serious adverse events, according to Government procedures and IAW 21 CFR 312.32 and 312.33 and ICH Guidelines
-Manage and process reported pregnancy cases through electronic systems, which may include but is not limited to data entry and preparation of narratives, generating and sending follow-up queries as appropriate until term, generating analyses of similar events, data element coding of event terms in the safety database utilizing the Medical Dictionary for Regulatory Activities dictionary and performing quality reviews of data entered into the electronic data management system and other systems as applicable
-Reconcile data and documentation in the Safety Database and the Clinical Database at a minimum annually before the annual report and before study database lock
-Develop and/or review protocol specific documents and clinical safety documents including but not limited to clinical protocols, informed consent forms, investigator brochures, data monitoring committee charters, safety management plans, safety surveillance plans, safety-related source document and other associated clinical safety documents
-Develop a protocol/product specific unblinding plan prior to the start of a clinical trial
-Work with clinical monitors and site staff to resolve issues and obtain needed documentation.
Must be a US Citizen or a full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
Tunnell Consulting, Inc., has served the pharmaceutical industry as scientific and technical consultants for over 50 years. In 2008, the Company established Tunnell Government Services, Inc. (TGS) as a wholly owned subsidiary to focus exclusively on government sector support. TGS currently provides support in the medical research and product development arena within the DoD (USAMRMC and Navy), HHS (BARDA and NIH), DHS (HQs S&T) and other federal agencies across the Public Health Emergency Management Countermeasures Enterprise (PHEMCE). Not just a source of laboratory research and support personnel, TGS brings established experience in practices that adhere to FDA guidelines and industrial acceptance. Our offerings include: Medical Product Development; CBRN and Emerging Infectious Disease Public Health Preparedness; Warfighter Protection; Biomedical IT; Healthcare and Medical Product Engineering/Technology; and Human Capital/Organizational Excellence. TGS provides a wide diversity of functional experts, from Ph.D level Immunologists, Biochemists, Molecular Biologists, Toxicologists, Physiologists and Veterinarians, etc. to research associate, research technician, research nurse, chemist, microbiologist, biologist, Principal Investigator and physiologist. With this background of work, relevant experience in both work and organizations, and robust recruitment capability, we feel confident that we can meet and exceed the challenges of our diversified customer portfolio.
Offices: 6701 Democracy Blvd., Bethesda, MD 20817, US
Integrated Scientific and Biomedical ServicesMedical Product Development including CountermeasuresPublic Health and Security related to CBRNEmerging Infectious DiseasesPandemic Influenzaand FDA and Clinical SupportBiotechnology
How many Healthcare jobs are open in Bethesda, MD right now?
There are currently 302 open healthcare positions in Bethesda, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Bethesda, MD?
Companies currently hiring include Guidehouse, Tunnell Government Services, Inc., Sunrise Senior Living, Akicita Federal, Axle, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Bethesda, MD?
Yes — 50 of the 302 open healthcare positions offer remote or hybrid work (25 remote, 25 hybrid).
How do I apply for Healthcare jobs in Bethesda, MD?
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