Associate Director, PSPV Compliance & Analytics

LanceSoft Inc; Cambridge (MA); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical compliance organization is seeking an experienced compliance professional to lead investigations of Individual Case Safety Reports (ICSR) and manage compliance metrics. Candidates should have a Bachelor’s degree and at least 5 years of experience in pharmacovigilance compliance. This role offers opportunities for career growth and remote work flexibility.

Benefits

Career advancement opportunities

Flexible remote work

Competitive salary and benefits package

Qualifications

• 5+ years of experience in pharmacovigilance compliance.
• In-depth knowledge of regulations and compliance.
• Experience with inspections and audit procedures.

Responsibilities

• Lead investigations of late Individual Case Safety Reports (ICSR) and implement corrective measures.
• Generate and analyze metrics for case processing and regulatory reporting.
• Oversee vendor management activities supporting Pharmacovigilance compliance.

Skills

Pharmacovigilance compliance

Data analysis

Project management

Interpersonal communication

Education

Bachelor’s degree in RPH, RN HCP, Life Science

Tools

Microsoft applications

Safety-related databases

Job description

Employer Industry: Pharmaceutical Compliance and Analytics

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Remote work flexibility available
- Engage in critical compliance and analytics functions that shape patient safety
- Collaborate with cross-functional teams in a dynamic work environment
- Competitive salary and benefits package

What to Expect (Job Responsibilities):
- Lead investigations of late Individual Case Safety Reports (ICSR) and implement corrective measures
- Generate and analyze metrics for case processing and regulatory reporting
- Develop compliance metrics reports for key stakeholders
- Oversee vendor management activities supporting Pharmacovigilance compliance
- Monitor and manage Corrective and Preventive Actions (CAPAs) to ensure timely completion

What is Required (Qualifications):
- Bachelor’s degree in RPH, RN HCP, Life Science, or related field
- Minimum of 5 years of relevant experience in pharmacovigilance compliance within the pharmaceutical industry
- In-depth knowledge of pharmacovigilance regulations and compliance
- Experience with inspections and audit procedures
- Proficiency in safety-related databases and Microsoft applications

How to Stand Out (Preferred Qualifications):
- Project management experience
- Post-graduate degree or equivalent in a related field
- Strong analytical and judgment capabilities
- Proven ability to work effectively with cross-functional teams
- Excellent interpersonal and communication skills

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