Contract Safety Operations Manager
- Remote USA
- Employment Type: Contract
- Required Therapeutic Area: none
- Minimum office time: NA
- Hours per week: 16
- Contract duration: 1 year
- Potential to convert to perm: No
- Travel expectations: No
Responsibilities
- Provide oversight of outsourced pharmacovigilance operations, including case processing, regulatory reporting, literature surveillance, and safety database activities.
- Serve as the primary operational contact and relationship manager for the CRO, ensuring adherence to service level agreements (SLAs), key performance indicators (KPIs), and contractual obligations.
- Monitor operational performance, quality, and regulatory compliance, and drive issue resolution, risk mitigation, and corrective and preventive actions (CAPAs) as needed.
- Lead routine governance meetings, review operational metrics, and communicate vendor performance and risks to internal stakeholders.
- Ensure inspection and audit readiness by maintaining appropriate oversight documentation and supporting internal and regulatory inspections.
- Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Safety, and other stakeholders to support successful pharmacovigilance operations.
- Identify and implement process improvements to enhance operational efficiency, compliance, and vendor performance.
Required / Preferred Experience, skills, and qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline; advanced degree preferred.
- Minimum of 7 years of pharmacovigilance or drug safety experience, including experience overseeing outsourced safety operations or managing CRO relationships.
- Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH guidelines, and GxP requirements.
- Experience with pharmacovigilance systems and safety databases (e.g., Argus Safety) preferred.
- Demonstrated experience in vendor management, operational oversight, quality management, and cross-functional collaboration.
- Excellent organizational, communication, problem-solving, and stakeholder management skills.
Additional Details
The Safety Operations Manager provides operational oversight of outsourced pharmacovigilance activities performed by the Company’s Contract Research Organization (CRO). This role is responsible for ensuring that safety operations are executed in compliance with global regulatory requirements, company procedures, and contractual agreements. The incumbent serves as the primary liaison with the CRO, overseeing vendor performance, operational compliance, quality, and continuous improvement to ensure timely and high-quality delivery of pharmacovigilance services.
Clin Ops Solutions is a specialized recruitment firm supporting the life
sciences industry with strategic placement of clinical development
professionals. We partner with biotechnology companies to provide both
business development solutions and recruiting expertise that help advance
innovative therapies and clinical programs.
Role Overview
We’re expanding and we’re looking for a clinical operations professioal who thrives on connection, collaboration, and results. As Director of Business Development, you’ll play a dual role: helping Clin Ops Solutions grow our client partnerships while also recruiting the clinical operations talent that drives biopharma success.
You’ll recive direct mentorship from our CEO, learning the business development and recruiting strategies that have helped Clin Ops Solutions become a trusted partner in the biopharma industry. This is a hands-on position where you’ll make an immediate impact.