Head Of Safety Science

Revance Newark , CA 94560

Posted 1 week ago

Position Summary:

The Head of Safety Science encompasses a key role in setting and executing departmental strategy and in managing the day-to-day functioning of the Drug Safety & PV department. This role collaborates with colleagues and vendors representing Clinical Science, Clinical Operations, Biometrics, Regulatory & QA and Legal. The incumbent will be the inaugural member of the Safety function at Revance and establish the infrastructure and key processes required to enable successful development of the company's aesthetic and therapeutic programs, thereby having significant influence on shaping the future of the Company.

Additionally, the role will have primary accountability for the role of Safety Lead across and will oversee the Safety deliverables for Revance's lead product, DaxibotulinumtoxinA for injection, including the development and execution of the long-range safety strategic plans for the molecule, including the design, monitoring, analysis, and reporting of studies and other data sources throughout the product lifecycle. The successful candidate will also bring safety expertise to the company's interactions with Health Authorities and Data Monitoring Committees and represent the Company at scientific meetings. They will perform as a hands-on leader who is both collaborative, a self-starter, and who has the ability to work in a matrixed environment.

Essential Functions:

  • Leads the establishment of the Safety Function to effectively manage PV within a small company as part of an evolving process from a pre-market, US-only setting, to post-commercial globalization.

  • Responds to the evolving regulatory environment with an emphasis on PV and drug safety, including REMS, PMCs, post-marketing surveillance and reporting of identified adverse reactions.

  • Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures

  • Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database

  • Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate

  • Liaises with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for assigned case reports

  • Leads bi-weekly clinical data review in collaboration with Clinical Development, Data Management and Clinical Programming

  • Manages communications with CROs regarding the evaluation and processing of case reports

  • Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems

  • Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns regarding Revance products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety

  • Manages the planning and preparation of the adverse events section of protocols and informed consents for clinical studies

  • Participates in the negotiation of safety exchange agreements (PVAs) with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission

  • Participates in the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of applicable safety data DB

  • Ensures that the applicable safety DB data with external groups such as the DM staff for clinical studies; Drug Safety personnel from partner companies, etc. is governed by Revance SOPs

  • Oversees the preparation of ASURS, DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports

  • Participates in the development and review of appropriate safety sections of IBs, CSRs, ISS, NDAs

  • Manages the process for identifying, evaluating, and selecting outsourcing vendors (CROs, Call Centers, safety DB vendors)

  • Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs

  • Reviews aggregate safety data from the clinical DB in support of Data Monitoring Committee meetings, interim analyses or final DB lock

  • Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems

  • Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development

  • Participates in the development and management of departmental budget

  • Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle

Preferred Experience:

  • Direct management responsibility over the safety function for a minimum of 5 years

  • Demonstrated experience in industry setting for at least 10 years

Preferred Education:

  • Medical Degree is required
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Safety & Security Manager

Lucid Motors

Posted 2 days ago

VIEW JOBS 3/21/2019 12:00:00 AM 2019-06-19T00:00 Safety & Security Manager Lucid's mission is to inspire the adoption of sustainable energy by creating the most captivating luxury electric vehicles, centered around the human experience. We constantly seek talented, motivated individuals possessing a proven track record of excellence to join our team. Become part of a once-in-a-lifetime opportunity to transform the automotive and mobility industry. We are currently seeking a Safety & Security Manager. This position requires an experienced professional with a background in Facilities Management, focusing on Safety and Security. This position will report to the Director of Facilities. Our ideal candidate exhibits a can-do attitude and approaches his or her work with vigor and determination. Candidates will be expected to demonstrate excellence in their respective fields, to possess the ability to learn quickly and to strive for perfection within a fast-paced environment. You Will: * Be responsible for the development and implementation of all applicable company safety programs based on Federal and Cal-OSHA regulations. This includes best practices of our industry and emerging issues as it relates to electronic vehicle manufacturing * Be responsible for developing security protocols for staff and visitors at all locations working with local law enforcement, company insurance personnel and corporate risk management * create and implement an effective corporate safety and security framework establishing strategic site-specific protocols and guidelines to create and maintain a safe and secure workplace for Lucid employees You Bring: * Safety and/or security designations such as CSP (Certified Safety Professional), ASP, (Associate Safety Professional), CIH (Certified Industrial Hygienist, CHPP (Certified Homeland Protection Professional), COSS (Certified Occupational Safety Specialist) or equivalent * Working knowledge of Cal -OSHA / Federal OSHA regulations as it applies to manufacturing operations, hazardous materials handling and storage, and Environmental compliance. Candidate will be able to prove a track record of working effectively with local authorities on Regulations, Codes, Standards, Directives, and Administrative Policies * Must be organized, have analytical skills, be detail-oriented, a problem-solver, project management skills and strong focus on results. * Good written and verbal communication skills, and able to work with employees at all levels of the organization * Experience developing and implementing goals and strategies based on broader organization goals * Active membership in the American Society of Safety Professionals (ASSP), American Industrial Hygiene Association (AIHA), American Society of Industrial Security Professionals (ASIS), InfraGard or equivalent Advantageous: * 10+ years' experience in corporate safety and security * 4+ years in a leadership role managing safety within a similar size organization Education Requirements: * Bachelor's Degree in Occupational Environmental Health & Safety or equivalent Be part of something amazing: Come work alongside some of the best and most accomplished minds in the industry. Based in the heart of Silicon Valley, California, Lucid Motors is making significant breakthroughs in clean technology. Beyond providing competitive salaries, we're providing a community for the brilliant minds who want to make an immediate and significant impact. If you want to actively work towards creating a better, sustainable future, we'd love to have you join our team! Lucid Motors is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, national or ethnic origin, age, religion, disability, sex, sexual orientation, gender identity and expression, marital status, and any other characteristic protected under applicable State or Federal laws an regulations. At Lucid, we don't just welcome diversity - we celebrate the differences that make up our team, our products, and our community. Lucid Motors Newark CA

Head Of Safety Science

Revance