What are the responsibilities and job description for the Senior Assoc Pharmacovigilance Operations position at Aditi Consulting?
Payrate: $22.00 - $25.00/hr.
Summary:
To support the safety surveillance process for products by performing follow up activities with patients and HCPs of individual case safety reports. Ensure vendor compliance with approved processes and training requirements. Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures. Point of accountability for managing one or more key vendor relationships for ICSR processing. Case processing point of contact for case related activities with assigned business partners. Case processing point of contact for audit related activities related to case processing. Accountable for measuring quality against contractual safety agreements. Accountable FDA point of contact for ICSR reporting. Submission of all individual safety reports to FDA, EMA and Business Partners.
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 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).
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 ArisGlobal) and medical coding.
- Comprehensive English writing skills.
- Excellent phone conversations skills.
- Comprehensive knowledge on MS Office applications.
Basic qualifications:
- Master’s degree, or equivalent experience:
- Bachelor’s 2 years
- Associate’s 6 years
- High school diploma/GED 8 years in [Job Code’s Discipline/Sub-Discipline]
Top 3 Must Have Skill Sets:
- Strong communication skills
- Prior pharmacovigilance experience or exposure
- Well organized
Pay Transparency: The typical base pay for this role across the U.S. is: $22.00 - $25.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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#26-03055
Salary : $22 - $25