278 Medications jobs in the United States

• Outreach, educate, and link Glide HEAT clients to methadone, suboxone, naltrexone, Brixadi and other medications that target opiate use disorder at GLIDE, at community events, and mobile outreach efforts.
• Build positive clinical rapport to maintain a productive and active caseload to promote medication adherence, increase stability and wellness, and apply harm reduction practices. Link and navigate MOUD clients to primary health care, appropriate mental health services, and assist clients in accessing housing and the necessary documentation to support stabilization and positive outcomes.
• Outreach, education and link client caseload to full range of Glide services as well as the relevant external community resources to achieve stability and self-sufficiency.
• Plan, conduct outreach for, and facilitate MOUD, treatment and other harm reduction groups on a regular basis.
• Document and maintain complete files on clients including updated intakes, assessments, case management notes, group attendance logs, referrals and other required data captures in a timely and accurate manner in accordance with program standards, organization policy, and applicable local, state, and federal laws for MOUD services. Submit monthly activity and data reports that capture contract deliverables in required database systems.
• Adhere to standard professional boundaries, understand and follow basic ethics and values of case management regulatory practices, and understand and adhere to HIPAA protocols.
• Develop and prepare outreach and educational materials targeted to engage the broader community in HEAT MOUD programs. Assist the leadership team in coordinating special events that promote HEAT MOUD efforts as well as the full array of HEAT and Glide wide programming.
• Participate in and support the full range of HEAT program services such as SAS, HIV/HCV/STI testing and navigation, mobile outreach services and community outreach programming when necessary.
• Participate and engage in regular professional engagements including individual supervision, team meetings, community meetings, trainings, and other professional develop opportunities that support GLIDE's overall organization goals and strengthens HEAT's service delivery systems and client outcomes.
• If needed, the MOUD case manager will be eligible for jail clearance in San Francisco and other Bay Area counties in order to enter city and county jails to advocate on behalf of incarcerated MOUD clients.

• Bachelor's degree in social work, public health or related field and/or 2+ years providing MOUD/MAT navigation and harm reduction focused case management services to high-risk populations, including knowledge providing prescriptions for suboxone, naltrexone and other medications (and methadone dispensaries) used to support treatment adherence for clients who access HEAT MOUD services.
• Must have experience and training in overdose reversals, de-escalation techniques, motivational interviewing. And experience providing street-based outreach services in urban settings and homeless encampments.
• Must have an understanding of the social determinants of health and how they impact people experiencing homelessness, actively engaged in drug use with proximate social stressors.
• Ability to establish and maintain effective collaborative relationships across Glide wide programs as well as with city agencies across San Francisco and the wider Bay Area.
• Must understand the core principles and practices of harm reduction and can successfully engage clients in services and retention through the application of risk reduction counseling, strengths-based counseling techniques
• Must have knowledge of the social determinants and health and be able to provide culturally competent, culturally sensitive support to a diverse community of clients to help them achieve stability and self-sufficiency.
• Exceptionally strong communication skills and trust-building skills are required, including comfort and proficiency with public speaking (i.e. 1:1 interaction with clients and community, group education, street outreach, etc.)
• California Rapid HIV/HCV/STI test counselor certification preferred (or have the willingness to be trained).

• GLIDE's buildings are located in the Tenderloin neighborhood.
• GLIDE maintains an "open door" policy to the community and its clients, who frequently enter and leave the building

• Ability to work on a computer and see details of objects at close range.
• Ability to hear within normal range, and communicate effectively (in person, telephone or Zoom).
• Finger dexterity and the ability to use all standard office equipment.
• Sit or stand comfortably, and the ability to navigate throughout office spaces (via elevator or stairs).
• Activities that occur frequently are sitting, standing, walking, and handling materials and supplies.
• Activities that occur occasionally are climbing stairs and manipulating fine objects with your fingers.
• Activities that occur infrequently are bending, squatting, twisting, reaching straight above and below shoulder level, carrying and lifting up to 40 pounds

With multiple programs in late-stage development, a robust clinical pipeline, and strategic alliances with top-tier biopharma partners, our client is entering a pivotal phase of growth. They’re looking for a seasoned drug safety physician to help shape a proactive, global pharmacovigilance function that will scale with the pipeline.

About the Role

The Vice President of Drug Safety & Pharmacovigilance will be accountable for drug safety and pharmacovigilance activities for all compounds and products. This role will be responsible for safety organization and activities, including case operations, regulatory compliance, drug safety quality management, signal detection, risk management, molecule oversight, and risk communication. This position is responsible for developing and executing plans to support the overall corporate goals of developing and delivering safe medicines to patients.

Responsibilities

• Provide proactive leadership and expertise to drug safety and pharmacovigilance functions, including activities for investigational and marketed products.
• The VP of Drug Safety and Pharmacovigilance will identify safety signals in the investigational programs and manage those signals.
• The management of safety signals requires clinical acumen to prioritize signals.
• The VP is expected to proactively interact with investigators and other medical staff to manage clinically important safety signals arising in clinical trials while ensuring their resulting clinical data ultimately supports labeling that clearly articulates the safe use of products.
• Manage all drug safety and pharmacovigilance operational compliance functions, and ensure compliance with applicable Pharmacovigilance regulations, guidelines, and agreements with Business Partners for the product portfolio at all stages of the product lifecycle.
• Responsible for safety organization and activities, including case operations, regulatory compliance, drug safety quality management, signal detection, risk management, molecule oversight, and risk communication.
• Lead Safety trend analyses, signal detection activities, and Safety data reviews.
• Ensure competent medical evaluation of all relevant safety information, including that from partners, regulatory agencies, clinical trials, scientific literature, and non-clinical studies for ongoing surveillance and signal detection.
• Provide clinical expertise and medical review of aggregate/individual post-marketing and clinical trial adverse event reports.
• Participate in developing signal detection strategies and programs (i.e., Spotfire, elluminate, etc.).
• Develop and maintain comprehensive PV agreements that facilitate an efficient exchange of safety information and an optimized global strategy for managing the risk-benefit profiles of the company's product.
• Assure required safety submissions are of the highest quality and submitted within regulatory timelines, including DSURs, PBERs, and PADERs.
• Support development and provide medical expertise to investigative brochures, Informed Consent forms, clinical trial (CT) protocols and amendments, and other related documents as it pertain to safety.
• Implement project-specific process documents such as Safety Management Plans, Safety Reporting Plans, and other Safety/Pharmacovigilance plans.
• Oversee the Risk Management and Risk Minimization Plans for all products.
• Contribute drug safety principles related to IB, SOPs, CT Protocols and Amendments, Informed Consents, Clinical Study Reports.
• Lead in the development of safety core data sheet and reference safety information (RSI).
• Manage all safety processes to ensure process flow is managed efficiently and effectively, including formulating and recommending process improvement changes.
• Provide oversight to all contractors and service providers that are part of the Safety team.
• Interact with Regulatory Authorities on all safety-related audits.
• Collaborate with cross-functional teams to provide clinical knowledge and medical guidance related to global safety/safety compliance.
• Support preparation for US and Non-US filing and labels.

Qualifications

• MD Degree or equivalent degree.
• At least three years of clinical experience post-qualification or equivalent.
• A minimum of 10 years of drug safety operations and pharmacovigilance experience, and at least five years of proven experience in a senior leadership role.
• Strong experience in PV operation and PV risk management is required.
• Demonstrated understanding of regulations, knowledge, and practices required for PV, including local/international GPvP guidelines, ICH guidelines, and industry practices.

Required Skills

• Highly developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations.
• Sound clinical judgment.
• Demonstrated record of being decisive and accountable for organizational performance with successful outcomes.
• Demonstrable leadership ability, skilled in strategic thinking, building alignment, innovative problem-solving, and driving team performance.
• Demonstrable expertise in clinical trials and post-marketing pharmacovigilance, signaling methodologies and tools, and working with outsourced service providers to achieve high-quality results.
• Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization.
• Detail-oriented and data-driven.