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Humacyte · 5 hours ago

Director, Pharmacovigilance

Durham, NC

Full-time

Hybrid

Director/Executive

10+ years exp

Humacyte Inc is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues. The Director of Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements, and providing strategic leadership for PV operations while collaborating across various teams to uphold patient safety and regulatory excellence.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

Provide PV medical and technical support to one or more clinical project teams to ensure the successful design and execution of Clinical Development Plans

Oversee vendors performing medical review of individual case safety reports (ICSRs) and aggregate safety reports on behalf of the company. Author analyses of similar events (AOSE) and provide medical review and comments for ICSRs

Partner with CROs to ensure safety reporting, tracking, and documentation meet internal SOPs and global regulatory requirements

Lead global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting

Drive inspection readiness and lead interactions with global health authorities for safety-related audits and inquiries

Contribute for preparation and submission of periodic safety reports (e.g., PBRERs, DSURs, PADERs, Annual Reports, Investigator’s Brochures) within required timelines

Contribute to the safety sections of clinical documents such as study protocols, clinical study reports, Investigator’s Brochures, and regulatory submissions

Support development, implementation, and evaluation of Risk Management Plans (RMPs) and post-marketing safety studies

Provide medical support for clinical trials, including review of safety queries, eligibility assessments, lab findings, ECGs etc

Collaborate with Data Management and PV vendors to reconcile adverse events between clinical and safety databases. Collaborate in data cleaning and review of Tables, Listings, and Figures (TLFs) before database lock

Work with the Head of Safety to develop medical safety strategies and achieve PV Medical Safety objectives and support regulatory submissions, including BLAs and clinical study reports

Accountable for medical evaluation/interpretation of aggregate data review, signal detection and evaluation activities and ad hoc safety assessments to proactively identify and manage potential safety issues

Organize and contribute to Safety Management Team (SMT) meetings to review and assess study-related safety data, ensuring timely communication of emerging safety concerns

Develop and author responses to PV-related health authority inquiries; represent PV in FDA and other regulatory communications

Author and maintain standard operating procedures (SOPs), Safety Management Plans (SMPs), and safety agreements with partners and CROs

Qualification

PharmacovigilanceDrug safetyRegulatory complianceMedical evaluationSafety data analysisMicrosoft Office SuiteLeadership skillsStakeholder managementAnalytical skillsScientific backgroundCommunication skillsCollaboration skills