Pharmacovigilance & Drug Safety Associate Director
Posted 3 days ago
discover internationalDenver (CO)
SENIORITY
Manager
About the role
Hi Network! Our client is urgently looking for a Drug Safety & Pharmacovigilance Associate Director to work remotely, for a 6 month-contract, extendable. Please find below the job description: Provide strategic leadership for drug safety and pharmacovigilance activities across multiple compounds in development. Develop and oversee clinical safety strategy, including signal detection, risk assessment, and proactive risk management. Serve as the primary point of contact for Drug Safety Operations, ensuring effective oversight of internal teams and vendors. Lead selection, governance, and performance management of Drug Safety CROs, including RFIs, RFPs, and data migrations. Develop, implement, and maintain pharmacovigilance SOPs covering signal detection, DSURs, and safety reporting. Review and approve safety content for regulatory and clinical documents such as protocols, IBs, CSRs, and RMPs. Ensure global regulatory compliance and support Health Authority inquiries related to safety and pharmacovigilance. Streamline safety processes across CROs and functions to improve efficiency, data quality, and compliance. Collaborate cross-functionally with Clinical Development, Medical Writing, Data Management, Biostatistics, Legal, and Regulatory Affairs. Provide medical safety expertise through case review, metrics oversight, committee participation, and ongoing safety surveillance. If you have experience with the responsibilities mentioned above, please send me your updated resume.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this
