Sr. Drug Safety Associate

Sr. Drug Safety Associate

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.

Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Description

Primary Duties

The Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives.

Job Responsibilities:

1. Support Senior Manager, Safety Data Collection, Clinical Trials with setting the safety operation strategy and establishing the safety report collection standards and processes for Pre and Post-approval Clinical Studies globally Senior Manager, Safety Data Collection, Clinical Trials 20%

2. Execute the development, maintenance and implementation of:

a. Controlled documents (SOPs), data handling conventions and other process documents for Clinical Trials and Post-Marketing Clinical Studies

b. Safety operational content and processes for Clinical Trial and Post-Marketing Clinical Study tools for report collection such as protocols, CRFs, SAE forms, Pregnancy forms

c. Tools and processes for database requirements and configurations to enable safety-related activities during studies

d. Training requirements and materials for Clinical Trial safety report collection

e. Report metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials 20%

3. Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, and Clinical Trials 15%

4. Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection:

a. Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans)

b. Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)

c. Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)

d. Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials 20%

5. Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials 5%

6. Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%

Qualifications

Education:

Minimum of Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required

Master's or Doctorate level degree in health care related profession preferred

Minimum Experience Requirements:

4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent

Experience interacting with clinical third parties (e.g., contract research organizations) preferred

Knowledgeable in Pharmacovigilance and GCP legislation required

Direct experience in GXP compliant quality systems preferred