Director, Medical Safety (Scientist)

If you are a reputed company Jazz employee please apply reputed company the Internal Career site reputed company is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists reputed company Medical Safety organization. In reputed company collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates reputed company Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives reputed company Medical Safety organization. In reputed company collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety reputed company the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions

• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness
• Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests / responses.
• Delivers clinical safety input into clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participate in and/or reputed company internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed.
• Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues / concerns to senior management in a timely and appropriate manner.
• Mentors and trains junior members of the Medical Safety team. Required Knowledge, Skills, and Abilities Minimum Requirements
• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills, as well as proven ability to effectively reputed company interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases. Required/Preferred Education and Licenses
• Requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline. Description of Physical Demands
• Occasional mobility reputed company office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery. Description of Work Environment
• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working reputed company of “normal” work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel. #LI-DM1 #LI-Remote reputed company is an equal opportunity/affirmative action employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company, Inc. is committed to fair and reputed company compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay range is: $200,000.00 - $300,000.00 Individual compensation paid reputed company this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay decisions. This range will be reviewed on a regular basis. At Jazz, your reputed company pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html

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