Vice President, Pharmacovigilance and Drug Safety (Galax)
: $92,650.00 - $145,640.00 /year *
: Executive Management
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Add your resume and apply to jobs with your Glassdoor profile. Create Profile. Job. Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.. Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.. Reporting to the Senior Vice President, Clinical Development and Medical Affairs, the Head of Pharmacovigilance (PV) and Drug Safety will lead a team to improve patients' lives and impact on overall Insmed results through robust safety evaluation expertise and medical innovation. This role is responsible for ensuring optimal patient safety as first priority by developing a state-of-the-art safety strategy, driving medical safety processes and capabilities and having accountability for safety compliance. The Head of PV and Drug Safety responsible for building an efficient team within the Medical Affairs organization and attracting, retaining and developing talent.. Manages an efficient and successful medical safety organization, which provides robust medical and science-driven contribution to risk-benefit evaluation throughout product lifecycle to enable Insmed to provide impactful therapies to patients worldwide.. Enhances scientific and clinical experience of staff through continuous training and coaching. Participates in building the talent pipeline for key roles in Medical Safety. Responsible for attracting, retaining and developing talent within the PV organization.. Prepares safety objectives and evaluates and manages performance of the PV team.. Accountable for the delivery of high quality, timely and standardized medical safety deliverables. Provides content guidance and functional approval, as needed, for all safety documentation.. Establishes and maintains common global processes and guidelines for medical safety assessment, analysis, and compliance, including documented guidance for coding and the assessment of causality/expectedness for adverse event reports, as required.. Ensures that medical safety signals from aggregate data are identified promptly and communicated/escalated appropriately, including oversight (as appropriate) of use of signal detection tools and other sources for potential product signals.. Maintains a close collaboration with global associates by proactively escalating potential safety issues / changes that affect the risk-benefit profile of our products. Reviews PSURs and RMPs as a delegated activity, when required. Leads and/or coordinates as appropriate the preparation of medical stewardship data/information for Insmed, crisis management teams, and Health Authorities.. Initiates and maintains productive cross-functional Medical Safety collaborations with colleagues from other functions, e.g. Clinical Development, Medical Affairs, Regulatory Affairs, Medical Information, Biostatistics, and QA, as well as externally with expert panels and other scientific contacts.. Medical degree required. Specialty Board Certification desirable. Useful additional degrees: Post-graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) strongly preferred.. A minimum 5 years of postdoctoral clinical experience required.. At least 12 years in drug development in a major pharmaceutical company, including a minimum of 10 years in a safety-related position.. Global Pharmacovigilance experience is strongly desired.. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.. Experience in responsible/leading roles in clinical or safety through complete submission process.. Experience in presenting clinical or safety data to major health authorities.. Strong leadership skills including coaching, motivating, and directing, and fostering teamwork. Ability to develop and maintain effective working relationships with subordinates, superiors and peers.. Strong negotiation and conflict management skills.. Experience in leading cross-functional, multi-cultural teams.. Experience in drug development, clinical trial methodology.. Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.. Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer. Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality