Director, Drug Safety Operations
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Director of Drug Safety Operations leading and overseeing safety reporting in clinical programs. Managing CRO relationships and ensuring regulatory compliance in pharmacovigilance activities.
Responsibilities:
- Oversee all safety reporting activities managed by CROs and consultants, including expedited reporting (SAEs, SUSARs) and periodic aggregate safety reports (DSURs, PSURs/PBRERs).
- Serve as the primary point of contact for CRO pharmacovigilance teams, ensuring clear communication, accountability, and delivery of safety obligations.
- Develop, negotiate, and manage PV sections of contracts, safety management plans, and operational agreements with CROs and consultants.
- Monitor CRO performance through KPIs, audits, and oversight activities, ensuring timely and accurate reporting to regulatory authorities, ethics committees, and investigators.
- Collaborate with internal stakeholders (Clinical Development, Regulatory Affairs, Quality, Legal) to ensure alignment on PV strategy and compliance.
- Provide oversight for case processing, medical review, and data reconciliation activities performed by CROs and consultants.
- Ensure compliance with global regulations (FDA, EMA, MHRA, ICH, GVP, etc.) and maintain inspection readiness.
- Support development and maintenance of internal PV policies, SOPs, and training programs.
- Participate in safety signal detection activities and safety governance committees, as needed.
- Oversee maintenance and compliance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events.
- Participate in regulatory inspections and PV audits to ensure quality, integrity, and compliance with pharmacovigilance and safety reporting requirements per SOPs and global regulations.
Requirements:
- Master’s degree or higher in a healthcare field.
- 10 or more years of pharmacovigilance experience, including at least 5 years in a leadership or oversight role.
- Strong experience managing CRO/vendor relationships, particularly in clinical trial safety reporting, including governance oversight.
- Deep knowledge of global pharmacovigilance regulations, GVP, ICH guidelines, and relevant reporting requirements.
- Experience with oversight of drug safety databases (e.g., Oracle Argus).
- Proven track record of ensuring compliance in a global PV environment.
Benefits:
- an annual target bonus
- equity
- a comprehensive suite of competitive benefits designed to support our employees’ overall well-being
Similar Jobs
Director, Solutions Strategy – Operations
Director of Solutions Strategy & Operations responsible for operational foundations in fast-growing functions. Building systems for technical teams with a focus on scalable solutions.
Product/Process Engineer, Broadband Operations
Product/Process Engineer leading the manufacturing lifecycle of optoelectronic products at Ciena. Ensuring production readiness, reliability, and performance for high-performance networks globally.
Associate, Market Operations
Associate, Market Operations ensuring integrity of DraftKings’ prediction markets. Manage market activities, provide operational support, and conduct surveillance in a dynamic regulatory context.
Senior Manager – Testing Operations
Sr. Manager Testing Operations at Luminare Health managing testing strategy and planning meetings. Leads testing programs ensuring business outcomes by developing consultative teams and engaging methodologies.
Community Operations Intern
Intern role in community operations directly engaging users through various interactions. Focusing on user behavior understanding and relationship building for growth opportunities.
Client Operations Associate
Remote Client Operations Associate role at Blyss Journeys, responsible for client requests and documentation in a flexible scheduling environment.
Lead, Executive Operations
Lead, Executive Operations to structure execution for CEO and leadership team. Collaborate with teams to translate priorities into actionable plans for improved clarity.
Lead, Executive Operations
Lead, Executive Operations focusing on building simple structures for the CEO and leadership team. Coordinating across functions to improve clarity and reduce friction in high-priority work.
Operations Executive – Junior Production Coordinator, 1–3 Years Experience
Operations Executive supporting residential interior fit-out projects and coordinating with internal teams for smooth execution. Ensuring positive customer experience and adherence to design standards.
Senior Operations Analyst
Senior Operations Analyst at Argano overseeing project data and delivery processes. Driving operational excellence and strategic initiatives with cross-functional collaboration and mentorship.
Lead IT Operations Engineer
Lead IT Operations Engineer managing cloud IT infrastructure and operations, focusing on Microsoft 365 and Azure configurations while ensuring security and efficiency.
Cloud Cost Analyst – Cloud FinOps
Cloud Cost Analyst optimizing cloud spend for the National Institute of Allergy and Infectious Disease. Collaborating with clients on financial operations and cloud economics best practices.
Country Study Operations Manager – France
Country Study Operations Manager responsible for study management in clinical trials at Parexel. Leading study activities and vendor management with a focus on patient well-being.
Revenue Specialist III
Revenue Specialist III responsible for investigating and designing strategic initiatives to improve revenue cycle performance. Analyze data trends and support billing processes in healthcare Finance sector.
Operations Director
Operations Director at Solenis managing operational performance across nine manufacturing sites in North America. Leading safety, compliance, quality, and continuous improvement efforts in a complex manufacturing environment.
Operations Associate
Operations Associate overseeing pre and post-trade processing for broker-dealer operations. Collaborating across teams to optimize financial operations and regulatory compliance.
Operations Associate
Operations Associate supporting the operational infrastructure of a globally distributed crypto wallet team. Managing internal coordination systems and driving cross-functional accountability.
Senior Manager – RCM – Coding Operations
Sr. Manager overseeing revenue cycle management and coding operations at US Anesthesia Partners. Providing leadership and expertise in coding edits and denials while improving operational performance.
Staking Operations Lead
Lead Staking Operations for network health at Solana Foundation. Focus on decentralization and maintain relationships with validators and stakers in the Solana ecosystem.
Global Operations Quality Manager
Global Operations Quality Manager at Syneos Health responsible for leading quality management in clinical trials. Ensuring compliance and collaboration within study teams to achieve quality goals.