Description
Clinical Trial & Pharmacovigilance Manager
Venesco LLC is seeking a Clinical Trial & Pharmacovigilance Manager to lead clinical operations and drug safety surveillance activities across multiple FDA-regulated clinical development programs. This individual will provide strategic oversight for clinical trial execution, adverse event management, safety surveillance, and regulatory compliance while leading multidisciplinary teams.
Requirements
Duties and Responsibilities
- Direct Phase I and Phase II clinical trial operations.
- Lead pharmacovigilance and safety surveillance activities.
- Develop and maintain product safety profiles.
- Oversee adverse event collection, coding, review, and reporting.
- Manage DSMB activities and implementation of recommendations.
- Ensure compliance with FDA, ICH, and sponsor requirements.
- Coordinate safety reviews, risk assessments, and signal detection activities.
- Lead development of safety management plans and surveillance plans.
- Manage cross-functional teams including monitors, safety personnel, and clinical operations staff.
- Support INDs, Investigator Brochures, DSURs, annual reports, and safety submissions.
- Develop SOPs and improve operational processes.
Minimum Qualifications
- Advanced degree in Clinical Research, Nursing, Pharmacy, Public Health, or Life Sciences.
- Minimum 10 years of clinical research experience.
- Demonstrated leadership of Phase I and Phase II clinical studies.
- Strong expertise in ICH-GCP and FDA clinical research requirements.
- Experience managing clinical operations and pharmacovigilance programs.
- Proven ability to lead multidisciplinary teams.
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.
Skills Required
- Advanced degree in clinical research, life sciences, or healthcare field
- 8+ years of clinical operations and safety experience
- Strong knowledge of ICH-GCP and FDA regulations
What We Do
Venesco, LLC is a government contractor providing management consulting, IT, healthcare, research & development, and mission-critical services to federal agencies.
