Drug Safety Physician
Proclinical is currently recruiting for a Drug Safety Physician for a global pharmaceutical company located in Bridgewater, NJ. Successful candidate will function as the Global Safety Leader (GSL) for an assigned portfolio of products in development and marketed products.
- Collate safety signals from local Reference Safety Information documents as provided by Regulatory Affairs.
- Maintain a bibliography for all CCSIs and medical justifications.
- Define the search strategy for scientific literature review.
- Cooperating with Regulatory Affairs regarding the document review process.
- Perform single case medical assessment, including the determination of seriousness, expectedness and listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
- Oversee, prepare and review scheduled Periodic/Annual Reports (FDA) and Periodic Safety Update Reports (FDA and Global Regulatory Agencies). Oversee, prepare and review responses to ad hoc regulatory safety queries.
- Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation.
- Provide review of and input into documents, including labeling, protocols, Investigator Brochure, and licensing agreements and medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.
- Provide medical advice to assure the quality, consistency, accuracy, and clinical relevance of safety reports.
- Provide drug safety support when appropriate for product acquisitions and legal issues.
- Provide drug safety input for individual product quality complaints, Health Hazard Evaluations, Field Alert Reports, Recalls and Dear HCP letters/communications.
- Communicate with and engage key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.
- Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the product portfolio.
- Provide medical safety monitoring for clinical studies in collaboration with S&T office and staff (e.g. inclusion and exclusion criteria, protocol procedures and waivers) as well as provide medical oversight for serious adverse event reporting and tracking, and communication of safety issues to staff, sponsors, and regulatory authorities.
- Review and approve protocols and other miscellaneous study documentation and identify potential product safety problems.
- Develop safety monitoring and reporting plans for clinical studies and ensure quality of medical program deliverables in accordance with quality assurance project plans and standards
Skills and Requirements:
- Health care professional with post graduate medical qualification (MD/DO or equivalent).
- 8-12+ years clinical/practical experience in a relevant clinical environment.
- Minimum of 2 years of Pharmacovigilance experience in Clinical Safety or Post-Marketing Safety including thorough knowledge of FDA and ICH safety reporting regulations and guidelines.
- Experience with regional, national and global regulatory authority is a plus
- Must have Strong oral and written communication skills
- Advanced analytical skills
- Sound medical judgment and decision-making capabilities
- Strategic thinking and facilitative leadership
- Fluent utility of office computer programs such as Excel, Word, and PowerPoint
- Sound organizational and prioritization skills
- Formal training in Epidemiology a plus
- Demonstrated skills for project management
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 (+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.