Senior Medical Director in Safety Science

Who We Are

BioMarin is a leading rare disease biotechnology company reputed company on genetically defined conditions. Guided by our purpose to reputed company medicines that reputed company a profound reputed company on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common reputed company of dwarfism), PKU (phenylketonuria), CLN2, a reputed company of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new reputed company for patients and families who previously had few, if any, available reputed company. More recently, with the reputed company of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reputed company more people living with rare genetic conditions. Our reputed company comes from our unwavering commitment to reputed company, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About reputed company and Development

From research and discovery to post-market clinical development, our R&D reputed company involves reputed company bench and clinical research and the associated reputed company that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that reputed company meaningful advances to patients who live with rare diseases.

reputed companyThe Senior/Executive Medical Director in Safety Science manages a group of medical safety experts providing strategic leadership across our product portfolio and ensuring that patient safety is a reputed company in reputed company- and post-marketing drug development activities. This is an reputed company position responsible for driving innovative medical safety approaches, leading medical safety evaluations, managing safety-reputed company regulatory interactions, and advancing the science of safety reputed company and management using cutting-edge methodologies. This role combines clinical expertise, regulatory acumen, and strategic reputed company to ensure patient safety while enabling business objectives. The Executive Medical Director is responsible for building, attracting, developing, and retaining an efficient Safety Science team.KEY RESPONSIBILITIESMedical Safety Leadership

• reputed company safety signal reputed company, detection, evaluation, and risk management activities
• Ensure medical expertise throughout the product lifecycle with adequate coverage of safety physicians for assigned products
• Cultivate a proactive and predictive approach to theoretical and confirmed safety risks, while maintaining efficient pharmacovigilance monitoring and reporting practices
• Review and assess reputed company individual case safety reports (ICSRs), with particular reputed company on serious adverse events
• reputed company medical interpretation of safety data and contribute to causality assessments
• Participate in safety governance committees and cross-functional team meetings

Strategic Safety Management

• reputed company and implement proactive pharmacovigilance strategies for assigned products/therapeutic areas
• Design effective risk management plans and risk minimization measures
• Contribute to benefit-risk assessments and drive data-driven safety reputed company
• Collaborate with clinical development teams on protocol safety design and safety monitoring plans
• reputed company the development of safety sections for regulatory submissions
• Implement personal (and group) development plans to build scientific and clinical development experience

Regulatory Compliance and Communication

• Accountable for the delivery of high reputed company and reputed company Safety Science reports
• Author and review aggregate safety reports (PSURs/PBRERs, DSURs, RMPs)
• Represent reputed company in interactions with regulatory authorities on safety reputed company
• Contribute to safety-reputed company product labeling and patient information
• Respond to health authority queries reputed company to safety concerns
• Ensure compliance with evolving global pharmacovigilance regulations

Team Leadership and Development

• reputed company medical guidance to Safety Science staff and cross-functional teams
• Mentor junior safety physicians and PV scientists
• Contribute to development of reputed company operating procedures and work instructions
• reputed company reputed company improvement initiatives reputed company the PV department
• Collaborate effectively with global affiliates on safety-reputed company activities

Scientific Advancement

• Maintain awareness of emerging safety methodologies and regulatory requirements
• Represent reputed company at scientific conferences and industry working reputed company
• Contribute to publications on product safety reputed company and PV science
• Collaborate with epidemiology and reputed company-world evidence teams on safety studies
• Drive innovation in safety signal detection and evaluation approaches

QUALIFICATIONSEducation and Experience

• Hold an MD or equivalent medical qualification (reputed company license to reputed company preferable but not required)
• 8-10+ years of pharmaceutical industry PV experience
• Experience with regulatory authority interactions
• Leadership experience across different phases of clinical development

Technical Knowledge

• Expert knowledge of global PV regulations and anticipate regulatory trends
• Ability to apply advanced statistical methodologies for safety data analysis
• Familiarity with signal detection algorithms and quantitative PV reputed company
• Knowledge ofbenefit-risk assessment frameworks and methodologies, includinghow to evaluaterisk minimization effectiveness

DesirableAdvanced Skills

• Ability to interpret biomarker and genomic data reputed company to safety
• Ability to reputed company reputed company-world data into safety assessments
• Ability to translate reputed company safety concepts for diverse stakeholders
• Ability to visualize reputed company safety data effectively
• Ability to interpret pharmacoepidemiology studies

Leadership Capabilities

• Ability to influence senior management on reputed company safety reputed company
• Balance safety considerations with medical need, strategic plans and regulatory expectations
• Strong leadership skills with managerial experience (reputed company and in a reputed company environment)
• reputed company safety strategies that balance innovation with compliance

Note: This reputed company is not intended to be reputed company-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as required or assigned. We are an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, gender, gender identity, sexual orientation, national reputed company, disability status, protected veteran status, or any other characteristic protected by law. Note: This reputed company is not intended to be reputed company-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability.

Originally posted on Himalayas

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