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Interact with and / or supervise Drug Safety / Pharmacovigilance CROs. Senior Director, Drug Safety & Pharmacovigilance. This role allows the incumbent to build the in-house drug safety function in a fast-growing biotech and have the pharmacovigilance responsibility across the proprietary Probody portfolio.
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The Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department.
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Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
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At least 5 years experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency. Aveo offers an exciting opportunity for an experienced Pharmacovigilance Director to join a rapidly growing biotech company and play an integral role in building a Pharmacovigilance infrastructure.
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At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required. You will serve as the primary pharmacovigilance lead on study teams and liaise with cross functional team members, as well as external vendors and services providers; performing drug safety study start-up, maintenance, and close-out activities.
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The Director, Pharmacovigilance Systems and Data Management (Dir, PV Systems & DM) will be responsible for overseeing various aspects of PV systems and data management, as it pertains to Safety database configuration, data integrity, regulatory reporting, license partner exchange, aggregate report and ad-hoc report generation, signal detection and management tool, and the safety service provider(s.
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Proactively develop and implement within PV department plans regarding quality, compliance and inspection readiness across Drug Safety & Pharmacovigilance department (both Clinical Safety & Postmarketing Pharmacovigilance.
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Position requires a bachelor’s degree in nursing, pharmacy, or other healthcare related field and a minimum of 10 years in Pharmacovigilance in the pharmaceutical or biotech industry. Knowledge of pharmacovigilance and ability to apply knowledge to the evaluation of safety concerns and minimization of patient risk throughout the life cycle of drug products.
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Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection-readiness activities.
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In your role as Senior Medical Director, Drug Safety & Pharmacovigilance, you will report directly to the Vice President, DSPV. If you have these qualifications, and are excited about a leadership opportunity in a fast-paced, growing drug safety & pharmacovigilance department, we encourage you to apply.
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Basic Qualifications: Doctorate degree and 4 years of global safety/ pharmacovigilance experienceOr. Bachelor’s degree and 10 years of global safety/ pharmacovigilance experience. Master’s degree and 8 years of global safety/ pharmacovigilance experienceOr.
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The Drug Safety & Pharmacovigilance Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned products throughout lifecycle.
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Masters degree and 8 years of global safety/ pharmacovigilance experience. Doctorate degree and 4 years of global safety/ pharmacovigilance experience. Global Pharmacovigilance Scientist Lead, Obesity - US Remote.
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Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and /Roche Standard Operating Procedures(SOPs.
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Title: pharmacovigilance Company: Inventiv Health Clinical
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