Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
About the Role
The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products throughout its lifecycle. This includes generating major pre- and post-marketing safety deliverables, signal detection, benefit-risk evaluation, and risk management activities. The role requires effective cross-functional collaboration and interface with external Regulatory Authorities.
Responsibilities
- Provide Medical Safety/PV inputs to assigned products, including Clinical Development programs, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs.
- Liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, DMCs, and other entities to ensure safety strategy and operational excellence.
- Provide Medical safety/PV inputs to the Commercial organization to support global launch activities for assigned products.
- Participate in the preparation and review of safety-related sections for clinical, regulatory, and scientific documents.
- Collaborate in the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation in all Reference Safety Information (RSI).
- Perform review of medical/scientific literature for signal detection and aggregate reporting.
- Conduct signal detection activities, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation of safety assessments.
- Chair the Safety Management Team (SMT) of products under authority and participate in other executive forums.
- Serve as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports.
- Contribute to the preparation of Risk Management Plans (RMPs) for assigned products.
- Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data.
- Ensure compliance with global PV regulations and guidelines, SOPs, and quality standards.
- Participate in inspection readiness activities, internal audits, and external inspections.
- Represent PV in cross-functional forums and committees.
- Contribute to key performance indicators to ensure PV excellence.
- Maintain knowledge of Jazz Pharmaceuticals indications for assigned products.
- Keep abreast of new PV/safety regulations and guidance from regulatory authorities.
Requirements
- Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards, and Good Pharmacovigilance practices (GVP).
- Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems.
- MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries.
- Working experience with PV audit process with active participation in Regulatory Authority Inspections is preferred.
- Ability to manage multiple tasks with deadlines in a fast-paced working environment.
- Knowledge of the drug development process.
- Requires a high level of initiative and independence.
- Must have excellent written and oral communication skills, resourcefulness, and personal organization skills.
- Demonstrated cross-functional teamwork.
- Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint, and Word.
- Some national/international travel may be required.
Skills
- Signal detection
- Benefit-risk evaluation
- Risk management
- Cross-functional collaboration
- Regulatory affairs
- Pharmacovigilance
- Medical Safety
- MedDRA coding
- WHODrug coding
- Report writing
- Data analysis
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Word
Location
- Remote
Work Type
- Full-time
Experience Level
- Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience.
Education Level
- MD required (or equivalent)
- Medical licensure in at least one state preferred
- Clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus
Salary/Compensations
- $212,000.00 - $318,000.00
Benefits
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
About the Company
- Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases, often with limited or no therapeutic options.
- The company has a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
- Jazz Pharmaceuticals' patient-focused and science-driven approach powers pioneering research and development advancements across its 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.
Equal Opportunity
- Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.