Clinical Trial and Pharmacovigilance Operations Manager

Duties

• Manage all aspects of safety pharmacovigilance (PV) for Food and Drug Administration (FDA) regulated clinical trials and emergency use applications across various disease areas and research programs.
• Perform sponsor's assessment of adverse event reports for seriousness, expectedness and causality, determine Food and Drug Administration (FDA) reporting requirements for individual cases, maintain serious adverse event safety database.
• Ensure studies are conducted in compliance with protocol, current Good Clinical Practices (cGCP), and relevant regulations and guidance.
• Develop and review clinical research protocols, monitoring plans, safety plans, and associated documents.
• Review investigational brochures, case report forms, and informed consent compliance.
• Review submissions to the FDA for regulatory compliance and quality.
• Serve as liaison between satellite trial sites and the Sponsor.
• Educate other investigators regarding regulatory requirements.
• Ensure PV and clinical operations activities comply with GCP, local regulations, and Standard Operating Procedures.
• Prepare for and manage audits and inspections; implement Corrective and Preventative Actions (CAPAs) and track their effectiveness.
• Develop and deliver training to internal teams and relevant vendors on safety reporting, GCP, and operational procedures.

Requirements

Conditions of employment

• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
• This position requires you to submit a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE450) upon entry, and annually thereafter.
• This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Secret security clearance
• Appointment to this position is subject to a one-year probationary period unless the appointee has previously met the requirements as described in 5 CFR Part 315.
• This position has a Temporary Duty (TDY) or business travel requirement of up to 15% of the time.

Qualifications

Who May Apply: US Citizens

DHA Research & Development (R&D) is participating in an alternative personnel system known as thePersonnel Demonstration Project (PDP). The DB-03 payband is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that fallswithin this payband equivalent, may not receive an immediate pay increase (promotion) if appointed tothis position. Future pay increases within the payband will be accomplished through the pay forperformance management system.

In order to qualify, you must meet the education and experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is .

Basic Requirement for Clinical Trial and Pharmacovigilance Operations Manager:

Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S.Department of Education at the time the degree was obtained.

You MUST submit copies of your transcripts supporting your education.

In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:

Specialized Experience: One year of specialized experience which includes:

1. Experience maintaining regulatory compliance in accordance with Food and Drug Administration (FDA) regulations, and Good Laboratory Practice (GLP) regulatory requirements.
2. Experience interacting with team members, varied groups, and/or types of internal and external stakeholders to ensure regulatory compliance and patient safety in clinical research.
3. Experience managing safety pharmacovigilance and clinical operations for regulated research trials
4. Experience developing and reviewing clinical monitoring plans, pharmacovigilance plans, clinical standard operating procedures, and/or regulatory safety reporting

This definition of specialized experience is typical of work performed at the next lower grade/level positionin the federal service (DB-02 / GS-12).

Education

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: .

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.

Additional information

• Male applicants born after December 31, 1959 must complete a Pre-Employment Certification Statement for Selective Service Registration.
• You will be required to provide proof of U.S. Citizenship.
• This position requires a 1 year probationary period during which the agency evaluates your fitness and whether your continued employment advances the public interest. In making this determination, the agency may consider your performance and conduct; agency needs and interests; whether your continued employment supports organizational or Government goals; and whether it promotes the efficiency of the Federal service. Continued employment requires written certification that it advances the public interest.
• Direct Deposit of Pay is required.
• This position requires you to submit a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE450) upon entry, and annually thereafter.
• Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
• Recruitment or relocation incentives MAY be authorized for highly qualified candidates.
• Multiple positions may be filled from this announcement.
• Salary includes applicable locality pay or Local Market Supplement.
• If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the information sheet.
• Payment of Permanent Change of Station (PCS) costs is not authorized, based on a determination that a PCS move is not in the Government interest.