Drug Safety Pharmaceutical Consultants

Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking accomplished Pharmacovigilance / drug safety experts for pharmaceutical, biotechnology, and medical device products, from preclinical studies to post-market product. The Pharmacovigilance Professional must have a strong background and demonstrable hands-on experience and skills. Qualifications / Responsibilities include: • Global pharmacovigilance and drug safety auditing, compliance, and remediation • Global processes and systems for pharmacovigilance and drug safety • Quality systems and processes related to Pharmacovigilance • Expertise in applicable US and EU laws, regulations, guidances, and best practices; detailed knowledge of current FDA regulations and expectations • Clinical trial and post-marketing case processing and reporting; gap analysis, audits and mock inspections; • Safety data exchange, quality agreements and quality management plans • Electronic data capture and data mining • Safety signal detection and analysis; safety review programs • Pharmacovigilance training and education • Ability to lead projects and meet crucial timelines • Superb written and oral communication skills • Excellent interpersonal and soft skills • Ability to solve problems using innovative techniques Educational / Experience Requirements include: • B.S. life sciences and 10 years’ relevant experience. Apply to: For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective, and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable, and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology. Apply tot his job