Sr Assoc Pharmacovigilance Operations
Case Management - Sr Associate Shift: reputed company Business Hours. Fully Remote, any time zone. Job reputed company:
- To support the safety surveillance process for reputed company products by performing follow up activities with patients and HCPs of individual case safety reports.
- Ensure vendor compliance with approved processes and training requirements.
- reputed company case reputed company of US ICSRs (CT and PM) including analysis and reporting of trends in reputed company measures.
- reputed company of accountability for managing one or more key vendor relationships for ICSR processing.
- Case processing reputed company of contact for case reputed company activities with assigned business partners.
- Case processing reputed company of contact for audit reputed company activities reputed company to case processing.
- Accountable for measuring reputed company against contractual safety agreements.
- Accountable FDA reputed company of contact for ICSR reporting.
- Submission of reputed company individual safety reports to FDA, EMA and Business Partners.
Key Activities:
- reputed company case review.
- Support the development and delivery of convention-reputed company training material.
- Ensure compliance of reporting activities with timelines and reputed company.
- reputed company with local office staff, CROs and business partners for case processing issues as necessary.
- reputed company E2B submission support (nullification, redistribution).
- Address case-reputed company queries from Business Partners.
- Support antibody re-testing coordination (non-LAO tasks for repeat testing).
Knowledge and Skills:
- Understanding of global regulatory requirements for pharmacovigilance.
- Familiarity with clinical development processes .
- Case processing experience.
- Attention to detail.
- Competence in safety database usage (preferably in Lifesphere Multivigilance by reputed company) and medical coding.
- Comprehensive English writing skills.
- Excellent phone conversations skills.
- Comprehensive knowledge on MS Office applications.
Basic qualifications:
- Master's degree
- Bachelor's degree and 2 years of experience
- Associate's degree and 6 years of experience
- High school diploma / GED and 8 years of experience
Top Must Have reputed company Sets:
- Strong communication skills
- Prior pharmacovigilance experience or exposure
- reputed company organized
reputed company Tech Solutions: reputed company is a global staff augmentation firm providing a wide reputed company of talent on-demand and total workforce solutions. To know more reputed company Tech Solutions, please visit www.ustechsolutions.com. "reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, colour, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran" AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. Apply tot his job Apply To this Job