Pharmacovigilance Clinical Program Manager

Overview

We are currently searching for a Pharmacoviligance Clinical Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

Duties & Responsibilities

• Oversee all aspects of the Center's Pharmacovigilance Program, which leads the process for safety signal management activities, and ensures the detection, assessment, understanding and prevention of safety events for each investigational product (IP) the Center manufactures for clinical research.
• Provide tactical leadership for the Center's Pharmacovigilance Program/Team.
• Create and adapt pharmacovigilance procedures based on prevailing domestic and international regulations, the Center's polices/procedures, etc.
• Review safety events for completeness and trends; analyze comprehensive safety data in consultation with PV team; communicate findings to the Center's Office of Regulatory Sciences.
• Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines.
• Draft, review and finalize PV data agreements with collaborators who receive Center- manufactured investigational products.
• Work with the Center's external partners to gather PV information/data and review it utilizing the PV data system platform (ARGUS).
• Author/provide strategic input or oversight for PV related sections of periodic regulatory documents (i.e. IND annual reports, DSURs, IB updates) according to the agreed process and timelines.
• Monitor and evaluate safety profiles of the Center manufactured investigational products to detect any change in risk profile.
• Collaborate with the Center's protocol operations, medical, quality and risk management teams to ensure coordinated and effective risk mitigation strategies throughout the product lifecycle.
• Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
• Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.
• Assign projects and set deadlines for PV Team staff and facilitate PV team meetings.
• Maintain knowledge of vaccine and monoclonal antibody safety profiles and product development status; review relevant biomedical literature or other scientific data.

Requirements

• Clinical Advanced degree (NP, PA, MD, etc.) is required.
• Minimum five (5) years' experience in PV with significant experience in preparing regulatory documents in a biotechnology, pharmaceutical company, government, or CRO environment.
• Knowledge of clinical trial and PV methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements in PV
• Experience with MedDRA and drug coding reviews.
• Strong experience in the conduct and management of clinical trials, especially phase I - III vaccine or monoclonal antibody clinical trials. Strong background in clinical trial drug safety is required
• An understanding of medical terminology and ability to summarize medical information is required.
• Personnel management experience is required.
• Strong attention to detail and follow-up skills is required.
• Must be flexible and willing to take on significant administrative responsibilities.
• Must take initiative and have ability to work independently and as a team member, offering assistance wherever needed.
• Must be able to create contingency plans to deal with possible challenges and roadblocks.
• Good computer and database skills, familiarity with ARGUS platform is preferred.

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Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...

• Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
• Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
• Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
• Discovery! With our tuition assistance and training programs, we support your career advancement.
• Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
• Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program, and membership to Care.com.
• Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
• A Voice! A unique culture where you can influence decisions and have your voice heard.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.