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US-PA-King of Prussia | US-MA-Waltham
Job ID 2018-1747
# of Openings 1
The Medical Director: This role will participate in oversight of all post-marketing and clinical safety and pharmacovigilance activities. Will ensure timely, consistent, and accurate safety reporting in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs), and standard operating procedures (SOPs).
Under the oversight of the VP of Pharmacovigilance, and in collaboration with key colleagues and stakeholders is responsible for ensuring appropriate medical safety assessments and surveillance, compliant regulatory reporting, development and implementation of benefit-risk management strategies and communication of safety information for assigned products globally.
Collaborate with the PV Medical Director to ensure investigational and post-marketing regulatory reporting and pharmacovigilance activities for assigned Global products.
Collaborate with the PV Medical Director to ensure development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products.
Collaborate with the PV Medical Director to ensure follow up on individual case safety reports from all sources for assigned products.
Prepare Periodic/Annual Reports (FDA) and PBRER/PSUR and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities)
Collaborate with the PV Medical Director to prepare, and respond to ad hoc regulatory queries, and signaling topic reports.
Assist the PV Medical Director in maintaining state-of-the-art pharmacovigilance processes and procedures within Radius Health, Inc. R&D, and as part of the PV Organization.
Collaborate with the PV Medical Director to ensure representation at drug development project teams; manage Safety Review Teams.
Collaborate with the PV medical director to ensure safety-labeling activities for assigned products.
Pharmacist, nurse or other relevant healthcare or life science discipline; Postgraduate degree desirable.
A minimum of 5-7 years of Pharmaceutical Industry experience within the Drug Safety Department required.
Ability to read, analyze and interpret scientific and technical journals.
Must have very strong English language writing skills and mature verbal communication and presentation skills.
Working knowledge of MedDRA coding and case series retrieval strategies.
Requires strong attention to detail in composing and/or proofing materials, establishing priorities, scheduling and meeting deadlines.
Ability to work independently, take initiative and complete tasks to deadlines.
Excellent interpersonal, analytical, managerial, and organizational skills.
Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation.
Knowledge of worldwide regulatory requirements and reporting of adverse events for both marketed and investigational products.
Global drug safety experience preferred.
Knowledge of Periodic Safety Update Report (PSUR) and the ability to interface with international partners a plus.
Post-marketing and investigational event and aggregate assessment/review/ documentation skills is preferred; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations.
A working knowledge of ICH guidelines and global regulations and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety is preferred.
Experience using a large-scale electronic data storage and retrieval system, preferred.
Ability to work with international collaboration partners and CRO's.
Ability to anticipate/identify problems and take appropriate action to correct.
Proficient in Microsoft Office Suite.