What are the responsibilities and job description for the Director, Pharmacovigilance position at Humacyte?
DEPARTMENT: Regulatory Affairs
LOCATION: Durham, NC; Partially Remote
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com .
JOB SUMMARY:
The Director of Pharmacovigilance (PV) is responsible for leading global drug safety activities and ensuring compliance with regulatory requirements for adverse event (AE) reporting. This position oversees the integrity of safety data across clinical and post-marketing programs, ensuring timely, accurate submissions to global health authorities and effective signal detection, risk management, and safety evaluation processes.
The Director provides strategic leadership for PV operations, collaborates cross-functionally with Regulatory Affairs, Clinical Development, and Data Management teams, and drives continuous improvement of PV systems and procedures to uphold patient safety and regulatory excellence. This role also contributes to medical safety strategy development and supports regulatory submissions, including BLAs and clinical study reports.
This full-time position may be performed remotely from any location within the continental U.S. and reports to the Head of Pharmacovigilance and Medical Monitoring.
Note: This position requires a Doctor of Medicine (MD).
ESSENTIAL FUNCTIONS:
The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.
LOCATION: Durham, NC; Partially Remote
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com .
JOB SUMMARY:
The Director of Pharmacovigilance (PV) is responsible for leading global drug safety activities and ensuring compliance with regulatory requirements for adverse event (AE) reporting. This position oversees the integrity of safety data across clinical and post-marketing programs, ensuring timely, accurate submissions to global health authorities and effective signal detection, risk management, and safety evaluation processes.
The Director provides strategic leadership for PV operations, collaborates cross-functionally with Regulatory Affairs, Clinical Development, and Data Management teams, and drives continuous improvement of PV systems and procedures to uphold patient safety and regulatory excellence. This role also contributes to medical safety strategy development and supports regulatory submissions, including BLAs and clinical study reports.
This full-time position may be performed remotely from any location within the continental U.S. and reports to the Head of Pharmacovigilance and Medical Monitoring.
Note: This position requires a Doctor of Medicine (MD).
ESSENTIAL FUNCTIONS:
- 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.
- MD required, with a minimum of 10 years of relevant pharmacovigilance/drug safety experience in the pharmaceutical or biotechnology industry.
- Strong scientific and analytical background with an expert understanding of global PV practices and regulatory frameworks.
- Proficient in validated safety databases and coding dictionaries (MedDRA, WHO Drug).
- Deep knowledge of U.S. and international PV regulations, GCP, and ICH guidelines.
- Demonstrated experience authoring and overseeing aggregate safety reports and addressing safety issues proactively.
- Comprehensive understanding of the end-to-end drug development process.
- Exceptional written and verbal communication skills with the ability to effectively present complex safety data to diverse audiences.
- Proven leadership, collaboration, and stakeholder management skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and safety data tools.
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays 2 Floating Holidays
- Paid Parental Leave Policies
The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.