Consultant - Senior Medical Safety Director
Proclinical is currently recruiting for a Senior Medical Safety Director for a pharmaceutical company located in Waltham, PA. Successful candidate will oversee the assessment of medical safety information including single cases and aggregate safety data for developmental and marketed products.
- Manage the Medical Drug Safety team within the Pharmacovigilance organization. Support and supervise staff and identify system and resource needs to ensure quality and compliant medical safety evaluation processes
- Oversee risk management and benefit-risk evaluation for clinical and post marketing programs
- Provide strategic leadership to improve the consistency and accuracy of medical assessments
- Lead the development and maintenance of general safety signal management methodologies and product specific signaling strategies
- Lead aggregate safety data reviews and the preparation of the medical content of periodic reports (including PSURs, DSURs) and ad-hoc reports
- Ensure that the safety profiles of products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required * Lead the preparation and delivery of high quality, consistent, and compliant safety information for regulatory (including IND and NDA) submission documents
- Oversee the development of relevant medical sections of responses to safety related health authority requests, various clinical documents including Investigator's Brochures, clinical protocols, safety management plans, study reports, and integrated analyses
- Organize and conduct quarterly Medical Safety Board meetings to review aggregate safety information and signal management for all products
- Lead regular and ad-hoc cross functional safety review teams. Represent pharmacovigilance on other multi-departmental projects
- Oversee and contribute to the preparation of safety reviews at Joint Safety Oversight Committee(s) for products developed and/or commercialized with external partners
- Oversee medical review of individual case safety reports (ICSRs) * Educate pharmacovigilance colleagues and others as needed on medical assessment, signal detection and safety risk management practices
- Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data
- Actively interact with external customers and service providers including business partners, CROs, system vendors and the call center
- Lead or contribute to the development and/or updates of relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates * Provide medical safety expertise for internal and external audits and regulatory authority inspections for Pharmacovigilance and ensure that relevant corrective actions are implemented
- Maintain an up-to-date working knowledge of applicable regulatory requirements, guidelines, and industry standards globally
Skills and Requirements:
- MD degree required
- 7-10+ years of relevant experience in the pharmaceutical/biotech industry in the areas of pharmacovigilance including safety signal management and benefit-risk assessment.
- 2+ years of experience in clinical practice or in academic medicine.
- Demonstrated ability to analyze and present complex pharmacovigilance data.
- Experience authoring medical evaluations and contributing to regulatory submissions.
- Strong competency in understanding the scientific background of disease mechanisms and medical therapies.
- Understanding of global pharmacovigilance regulatory requirements and guidance documents.
- Ability to lead and influence decision making around multifaceted issues involving medical safety.
- Excellent leadership, communication and organizational skills.
- Ability to think strategically and communicate complex issues clearly.
- Proficiency in the use of MS Office and other relevant cloud-based applications.
- US Board Certified or eligible preferred.
- Experience in global drug development including epidemiology, clinical research, medical affairs or another relevant field.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Yannick Dada at (+1) 646-741-8433 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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