Phone: (267) 948-1441
Position Overview
Our client is a publicly-traded biopharmaceutical company founded with a mission to discover, develop, and commercialize innovative first-in-class medicines that address significant unmet medical needs and advance patient care. They plans to launch the company’s first-in-class, novel mechanism therapy, approved for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, in the second quarter of 2022. Also, they are also pursuing approval of tenapanor, an investigational first-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 functions
- Previous experience with leading strategic safety medical evaluation activities at a product level is required
- Experience writing/leading pharmaceutical regulatory or clinical research safety documents, including periodic safety reports, IB safety sections, and risk management plans required
- Experience with safety databases, including medical review of case reports (pre-marketed and post-marketed products) required
- Familiarity with US and International Safety reporting regulations and guidelines
- Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization
- All employees must be fully vaccinated against COVID19
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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