Job Description

Associate Medical Director, Drug Safety Physician

• PC 3

Research & Development - Waltham MA

Your Tasks :

Reporting to the Global Head of Pharmacovigilance, with dotted line reporting to the 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, in both clinical trial and post-marketing settings.

The AMD / MD, Safety Physician will oversee the assessment and interpretation of safety data from multiple sources, including clinical trials, solicited sources, spontaneous reports from healthcare 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 assess adverse events reported from clinical trials and post-marketing surveillance, including seriousness, expectedness, causality, coding using MedDRA, evaluation for safety signals, and expedited reporting requirements.
• Develop protocol-specific safety definitions in collaboration with clinical trial teams, including medical leads, nonclinical experts, translational medicine experts, and engineers, to define data acquisition strategies and safety evaluation methodologies.
• Serve as drug safety representative on clinical trials involving CROs.
• Lead or contribute to Safety Management Teams.
• Advise on safety concerns and contribute to regulatory responses regarding safety questions.
• Identify potential safety signals by analyzing adverse event data, conducting signal detection activities, assessing impact on product safety profile, and proposing actions.
• Lead the analysis and evaluation of safety signals from internal and external data sources to determine risks that may lead to label changes or benefit-risk profile adjustments.
• Contribute to developing and implementing risk management plans, including safety communication strategies.
• Support the preparation of regulatory filings, including safety sections, ADR search criteria, and analysis of adverse events.
• Develop safety sections for product labels and contribute to safety data interpretation for clinical and regulatory teams.
• Author safety sections of global regulatory inquiries and reports such as DSURs, PADERs, and PAERs.
• Prepare updates for Investigator Brochures and Patient Informed Consent Forms.
• Communicate effectively with internal stakeholders (clinical development, medical, regulatory) and external agencies (FDA, other regulators, license partners).
• Stay updated on trends in PV/safety regulations, SOPs, scientific literature, and emerging safety concerns.

Requirements :

• MD with medical licensure; additional licensure in at least one region preferred; clinical research or fellowship in internal medicine, oncology, or relevant specialty is a plus.
• Minimum 3 years in Drug Safety / Pharmacovigilance, including early and late phase safety strategy development and risk mitigation.
• Strong knowledge of drug development processes.
• Experience with regulatory agencies like FDA, EMA is preferred.
• Organized, independent, self-motivated, effective in matrix environments.
• Excellent communication skills, both written and oral.
• Collaborative mindset with entrepreneurial vision, capable of working cross-functionally in a dynamic environment.

Physical Demands :

Must be able to walk, use hands, reach, talk, hear, stand, climb, stoop, kneel, crouch, or crawl. May need to lift/move up to pounds. Visual requirements include close, color, peripheral, and depth perception, and focus adjustment. Ability to multitask and work efficiently at a rapid pace while maintaining attention to detail.

Work Environment :

Work is performed in various facilities, including a temperature-controlled home office. Travel to customer sites and external environments may be required, with adherence to SOPs and PPE for handling research/clinical equipment.

The hiring range is expected to be between $,-$, reflecting considerations such as experience, internal equity, and qualifications.

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