Associate Medical Director, Drug Safety Physician *PC 1483

Your Tasks:

Reporting to Global Head of Pharmacovigilance, with dotted line reporting to Chief Medical Officers (CMO) for assigned products, the Associate Medical Director/ Medical Director AMD/MD, Safety Physician will be responsible for evaluating and assessing the safety of Miltenyi Biomedicine products globally as assigned, in both the clinical trial and the post-marketing setting.

The AMD/ MD, Safety Physician will oversee the assessment and interpretation of safety data from multiple sources, including but not limited to clinical trials and other solicited sources, spontaneous reports from health care providers and patients, and literature reports.

The role will also ensure compliance with all applicable US and foreign regulatory requirements for detection, evaluation, and risk management of Miltenyi Biomedicine products.

Essential Duties and Responsibilities:

• Review and medical assessment of adverse events reported from clinical trials and post-marketing surveillance, including assessments of seriousness expectedness, causality, coding using MedDRA terminology, evaluation for evidence of a potential safety signal, and assessment of the requirements for expedited reporting.
• Contribute to development of protocol specific safety definitions, in collaboration with multi-departmental clinical trial team members, such as clinical medical leads, nonclinical experts, translational medicine experts, and engineers to define data acquisition strategy, methodology, and approach for safety evaluations.
• Serve as drug safety representative on clinical trials with CRO participation.
• Lead or contribute to assigned Safety Management Teams.
• Advise on safety concerns.
• Contribute to regulatory responses to safety questions.
• Identify potential safety signals by analyzing patterns in adverse event data and conducting signal detection activities. Execute globally established signal assessment strategy; assess potential impact on the Miltenyi Biomedicine product safety profile with recommendation for action and initiate proposal for Safety Management Team.
• Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile.
• Contribute to the development and implementation of risk management plans to mitigate safety concerns associated with a drug, including developing safety communication strategies.
• Support preparation of registrational filings, contributing to the development of safety sections, ADR search criteria , individual and aggregate analysis of adverse events.
• Contribute to the development of safety sections for product labels.
• Work closely with clinical teams and other relevant stake holders to interpret safety data, develop presentations, and applicable regulatory documents.
• Contribute to or lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports. Such reports include Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Post Safety Update .
• Prepare updates on safety sections of Investigator Brochures and Patient Informed Consent Forms.
• Responsible for effective execution, communication, and influence with internal stakeholders (e.g., clinical development, medical, regulatory) and external stakeholders (e.g. FDA, other regulatory agencies, and license partners, as applicable).
• Stays abreast of current and emerging trends on PV/safety regulations and guidance from the regulatory authorities, SOPs and quality standards, latest scientific literature related to drug safety and emerging safety concerns.

Requirements:

• MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, or other relevant specialty is a plus; Minimum 3 years of Drug Safety/Pharmacovigilance Development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
• Excellent knowledge of drug development processes.
• Exposure to working relationships with the FDA, EMA and other regulatory authorities is preferred.
• Organized, independent, self-motivated, and demonstrated ability to work effectively in an advanced matrix structure.
• Strong presentation, written, and oral communication skills.
• Entrepreneurial vision: demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

The hiring range for this position is expected to fall between $222,500-$261,700, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biomedicine, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

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