Team Lead – Operations, Neurology
WashU IT
Executive Vice President, Pharmacovigilance Operations
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- The Executive VP, Pharmacovigilance (PV) Operations is responsible for leading and overseeing all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards.
- This role will manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality.
- Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations.
- Develop comprehensive operational strategies that align with the company’s overall objectives.
- Lead, mentor, and develop PV operational teams, fostering a culture of accountability, high performance, and continuous learning.
- Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums.
- Champion a culture of excellence across global PV operations, embedding best practices, innovation, and continuous improvement to enhance patient safety outcomes.
- Collaborate with Enterprise PMO/BPO to optimize and standardize end-to-end pharmacovigilance process.
- Drive global harmonization of PV processes across regions, affiliates, and partners to ensure consistent execution and regulatory alignment.
- Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs and enhances corporate decision-making.
Requirements
- Ideally an Advanced degree
- 15 + years of pharmacovigilance experience, with at least 10 years in an operational leadership role with P&L responsibilities
- In-depth knowledge of global PV regulations, GVP modules, and drug safety principles
- Proven track record of managing PV operations in a global environment within a CRO or PV service provider
- Strong leadership, project management, and strategic thinking skills
- Excellent communication, negotiation, and interpersonal abilities
- Experience with safety databases (e.g., Argus, ArisG) and PV software tools
- Strategic leadership and decision-making
- Operational excellence and process improvement
- Regulatory compliance and risk management
- Cross-functional collaboration
- High attention to detail and analytical skills
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilanceglobal PV regulationsGVP modulesdrug safety principlesoperational leadershipP&L responsibilitiesprocess improvementregulatory compliancerisk managementproject management
Soft skills
leadershipstrategic thinkingcommunicationnegotiationinterpersonal abilitiesattention to detailanalytical skillscross-functional collaborationmentoringaccountability
Certifications
Advanced degree
