Aptask Global Workforce (AGW) is seeking a Senior Associate, Pharmacovigilance Operations for a Remote position with a Global Biotechnology Company. This is a 6-month contract opportunity. This role is focused on supporting the safety surveillance process by performing follow-up activities for individual case safety reports. The ideal candidate will ensure vendor compliance, oversee case quality, and act as a point of contact for case processing and reporting to regulatory agencies like the FDA and EMA.
Responsibilities: - Perform case review
- Support the development and delivery of convention-related training material
- Ensure compliance of reporting activities with timelines and criteria
- Interface with local office staff, CROs and business partners for case processing issues as necessary
- Provide E2B submission support (nullification, redistribution)
- Address case-related queries from Business Partners
- Support antibody re-testing coordination (non-LAO tasks for repeat testing)
Requirements: - Master's degree
- OR Bachelor's degree and 2 years of relevant experience
- OR Associate's degree and 6 years of relevant experience
- OR High school diploma / GED and 8 years of relevant experience
- Strong communication skills
- Prior pharmacovigilance experience or exposure
- Well organized
Desired skills: - Understanding of global regulatory requirements for pharmacovigilance
- Familiarity with clinical development processes
- Attention to detail
- Competence in safety database usage (preferably in Lifesphere Multivigilance by ArisGlobal) and medical coding
- Comprehensive English writing skills
- Excellent phone conversations skills
- Comprehensive knowledge on MS Office applications
Pay range: up to $27.91 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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