Sr. Pharmacovigilance Quality Assurance Associate

Duties:

• Support the evaluation and acceptability of vendors, partners and other external organizations related to PV activities
• Conduct risk assessments of vendors, partners, and other external organizations related to PV activities.
• Conduct and/or assist with Pharmacovigilance external supplier audits (such as PV vendors and Specialty Pharmacies) including planning, execution, and reporting
• Review and approve internal and external Deviations, Quality Events, CAPA, Effectiveness Checks and Root Cause Analysis Investigations
• Assist in the review and provide input into the quality sections of the Pharmacovigilance System Master File

Qualifications:

• Minimum BS degree in Chemistry, Biology or related life sciences discipline required with minimum 4-5 years of experience, 2 years of which are in Pharmacovigilance
• Advanced degree (MS, PhD, MBA) preferred.
• Basic knowledge of Adverse Event (AE) reporting requirements and pharmacovigilance principles
• Basic knowledge of vendor management and contract management related to PV activities with business partners and external vendors such as Specialty Pharmacies, Patient Support Programs, Named Patient Programs, Market Research, and Market Access is required
• Basic knowledge of adverse event reporting requirement clauses within contractual agreements such as Safety Data Exchange Agreement (SDEA) with business partners, and Master Service Agreements/Statement of Works with vendors/third parties (i.e. Patient Support Programs, Specialty Pharmacies) is required.
• Basic knowledge and understanding of global pharmacovigilance regulations and guidelines, including, FDA, EMA and ICH regulations is required.
• Experience developing SOPs, reviewing pharmacovigilance, clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is preferred.
• Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs is preferred.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Pay Scale:

$93,000 - $100,796 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.