Integra LifeSciences Director, Medical Safety in Plainsboro, New Jersey
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Responsible for leading global Medical Safety vigilance activities for the complete life cycle of products from all Integra divisions, from product development to post market surveillance. The Director will act as the point person for risk assessment and safety surveillance as it relates to Product Development, Clinical Affairs and Quality/Regulatory Affairs. The Director will serve as vigilance expert to internal and external customers, providing key clinical, operational and strategic input to all matters of device safety. The Director will collaborate across functions, divisions and regions in risk management document development, safety planning in clinical trials, safety surveillance for signals and case investigation, risk benefit assessments, communication of safety information and other medically relevant information. Behavioral competency in collaboration and the ability to lead through influence are critical to success in this role.
To succeed in this role, an individual will perform the following:
Lead all aspects of product safety and vigilance activities across multiple technologies including implantable medical devices, surgical instruments, human tissues and consumer products, ensuring that our products are evaluated for safety and compliance and that product risks are managed and remediated
Act as Medical Safety lead for Safety Board and other cross-functional teams, providing medical perspective and expert guidance on product safety and risk-benefit assessment.
Provide key operational and strategic input around device vigilance and surveillance of patient and user safety signals to stakeholders regarding collection, evaluation and processing of adverse experience reports from a medical perspective.
Develop, implement and maintain Medical Safety policies and procedures in compliance with regulations and SOPs for medical input into global adverse event tracking and internal/external safety reviews.
Participate in SOP and Work Instructions development for safety data collection, tracking and compilation for related departments such as Medical Affairs, Clinical Operations, Regulatory and Quality.
Offer medical and safety expertise to product development (e.g. medical input to risk management documents such as Risk Plan, Hazard Analysis, FMEA), technology development, business development & licensing groups as needed.
Communicate safety information and other medically relevant information to all divisions and in all regions
Prepare, track, and manage a cost center budget.
Recruit, hire, train and manage global clinical safety staff, as required.
Ensure effective safety strategies are in place for the product innovation pipeline, delivery of safety aspects for clinical development, lead safety signal detection, develop risk management plans, provide relevant regulatory safety documentation and evaluate benefit-risk assessment
Ensure evaluation, communication and implementation of risk mitigation activities and be prepared to act as the physician spokesperson for safety matters on behalf of Integra internally and externally, as appropriate
Lead the long-term safety-related business processes and systems that will support a safe and compliant product portfolio for the company
Prioritize, drive and communicate the product safety activities within review and remediation programs
Provide clear guidelines and set corporate policies on key safety decisions including product safety classification (CLP), Product Safety Evaluation Report (PSER), Postmarket Safety Update Reports (PSUR) and the approach to Product Safety Data Sheets (PSDS) and Material Safety Data Sheets (MSDS).
Write (or lead the writing of) a Safety Plan for each individual clinical study
Ensure proper Medical Monitor oversight for Clinical studies through personal oversight or by engaging an appropriate Subject Matter Expert (SME) according to the Safety Plan
Provide appropriate Safety Reports consistent with specifications identified within the Safety Plan
Establish Data Safety Monitoring Boards (DSMBs), Data Monitoring Committees (DMCs), Clinical Events Committees (CECs), etc. and author documentation required for formation and operation of these bodies (e.g. Charters)
Conduct or oversee the review Adverse Events and Serious Adverse Events for each clinical study to ensure proper adjudication, escalation, and reporting to regulatory agencies according to the Safety Plan for formal reports (e.g. Clinical Study Reports, Annual Reports, etc.)
Must hold themselves, upstream stakeholders, and downstream stakeholders accountable to ensure timely reporting to ensure Serious Adverse Events from clinical studies are properly reported to regulatory agencies in a compliant and timely manner
Act as a Subject Matter Expert (SME) to ensure accurate and consistent MedDRA coding in study databases through the safety review and adjudication process
Review and approve narratives for Serious Adverse Events prepared by study teams
Liaise with Safety Board to ensure proper safety signals are identified and escalated. Communicate with study teams regarding status of applicable new, existing, and closed safety signals
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education, type and number of years’ experience
Licensed MD or DO with a minimum of 3 years industry experience required.
Previous Medical Device (preferred) or pharmaceutical safety vigilance experience required, ideally pre- and post-market.
Solid knowledge of general medicine and clinical practice, evidenced by accredited medical training. Previous medical practice experience and surgical background preferred.
Strong working knowledge of FDA regulations/ICH guidelines.
Experienced reviewer of safety reviews in summaries of safety in regulatory submissions, investigator brochures, clinical protocols and clinical study reports.
Experience developing and managing a safety function within industry preferred.
Leadership skills with a high level of behavioral competency in team work and collaboration
Ability to read, analyze and interpret clinical data information.
Strong skills in writing, verbal communication and presentation.
Strong attention to detail in writing and/or proofing materials.
Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
Ability to work independently; take initiative and complete tasks to deadlines.
Ability to form strong and constructive internal as well as external professional relationships.
Excellent organizational and management skills.
Vacancy ID 2018-27583
Position Type Regular Full-Time
Category Medical Affairs