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    1 day ago

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    1 day ago

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    22 hours ago

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    6 days ago

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    3 days ago

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    6 days ago

    Massachusetts, United States EPM Scientific Full time

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    1 day ago

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Head Of Drug Safety

2 months ago

Massachusetts, United States findojobs.us Full time

Our client is a publicly-tradedbiopharmaceuticalcompany founded with a mission to discover, develop, and commercializeinnovative first-in-class medicinesthataddresssignificant unmet medical needs and advance patient care. They plans to launchthe company's first-in-class, novel mechanism therapy, approvedfor thetreatmentofirritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022.Also, they are also pursuing approvaloftenapanor,an investigationalfirst-in-class phosphate absorption inhibitor that has completed three successful phase 3 trials.
The Head of Drug Safety will be responsible for medical safety for investigational and/or marketed products, including review and analysis of safety data, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products.The ideal candidate will not only be responsible for medical safety but also be strategic in their thinking in order to understand the impact of safety on the Company's commercial products, product licensees, as well as drug development candidates.
This position will have a high degree of visibility and impact across the organization.This role will report to the Chief Regulatory Affairs and Quality Assurance Officer.
JOB RESPONSIBILITIES
Role is responsible for leading product level safety analysis and strategic medical safety management for global products throughout the product lifecycle
Accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues
Leads safety signal detection activities and chairs global cross-functional safety teams, with appropriate communication/escalation
Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information
Completes/reviews medical assessments of safety data (Periodic Safety Update Reports (PSURs, DSUR), safety sections for labels/IBs/regulatory submissions (e.g. IND/pre-NDA briefing books, safety queries), Safety Surveillance Plans, and CCDS) as appropriate and ensures the benefit/risk information is accurate
Risk management activities, including risk strategies for assets in all phases of development and life-cycle
Routine PV activities of assigned programs including medical review, analysis of similar events, and literature review
Coding reviews and reconciliation activities in collaboration with Data Management
Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs)
Develops and implements strategies for pharmacovigilance business plans in accordance with long-term company strategic plans
Contribution to regulatory submission documents, response to queries and other regulatory inquiries
Performs aggregate analyses of specific events across studies, prepares and presents safety analyses at the Safety Committees, and writes Safety Assessment Reports
Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements
Supports the safety department in organizing post-marketing activities in all applicable regions
Contributes to and reviews SOPs
Prepares for regulatory inspections and audits and develops corrective action plans when needed
Prepares training material / Presentations for internal and external medical safety presentations
Performs other departmental duties as assigned
JOB REQUIREMENTS
Medical Degree (MD) with a minimum of 8 to 10 years in the pharmaceutical or Biotech industry with at least 5 years of experience in the US and international Drug Safety, Medical Affairs, and/or Clinical Development functionsPrevious experience with leading strategic safety medical evaluation activities at a product level is requiredExperience writing/leading pharmaceutical regulatory or clinical research safety documents, including periodic safety reports, IB safety sections, and risk management plans requiredExperience with safety databases, including medical review of case reports (pre-marketed and post-marketed products) requiredFamiliarity with US and International Safety reporting regulations and guidelinesStrong interpersonal skills and ability to collaborate effectively with other groups in a matrix organizationAll employees must be fully vaccinated against COVID19
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