The Role

Maintain oversight of the Pharmacovigilance System and to maintain an overview of the safety profiles and any emerging safety concerns in relation to Mineralys Investigational Products. Lead all pharmacovigilance risk management issues for the company

What you will do:

• Build and maintain a compliant global pharmacovigilance system.
• Develop and execute clinical safety educational training programs for personnel.
• Having an oversight on Individual case reports (ICRs), Standards Operating Procedures (SOPs), Risk Management Plans (RMP), Risk Minimization Strategies, effectiveness of follow-up measures, on safety data base, on e-transmission and on important observations from QA audits of PV activities
• Ongoing monitoring of the safety profile of Mineralys investigational product and continuous overall Pharmacovigilance evaluation during the post-authorization period.
• Ensure that any request from the Regulatory Authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by an investigational product is answered fully and promptly.
• Responsibility for oversight of any post-authorization Pharmacovigilance commitments and risk management activities for medicinal products
• Review and sign off documents such as Development Safety Updates Reports (DSURs), Risk Management Plan, clinical expert reports, literature review, and product information, particularly asthey relate to drug safety, to assure that quality is maintained, and that benefit/risk information is accurate and not misleading.
• Ensure compliance with EU & Global Pharmacovigilance regulations.
• Act as the internal safety resource in connection with safety issues.
• Support other departments in safety issues, i.e. participate in the preparation of local informed consent and ‘safety-sections’ of development protocols, investigator’s brochure, and other relevant regulatory filing documents.
• Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information.
• Obtain and verify new information concerning Pharmacovigilance legislation.
• Proactively manage outsourced activities.

Broad Function     

Principal Responsibilities

1. The position will be responsible for technical leadership of analytical development within the CMC function.
2. The position will ensure success on all drug substance and drug product deliverables by leveraging internal and external resources
3. The position will be responsible for strategic and scientific alignment of analytical development activities with the overall program needs
4. The position owns the delivery of product development initiatives/projects with emphasis on analytics for the development of NDAs through various milestones of product development.
5. Apply high quality standards/ principles during the different stages of product development, including review of drug product & API characterization, raw material quality attributes, design of experiments, stability testing, analytical methods development & validation/optimization, and statistical evaluation of data.
6. Evaluate the characterization and comparability plans and reports for complex dosage forms and propose techniques as needed.
7. Proactive management of project risks, opportunities and establishing comprehensive mitigation plans when it comes to product development/analytical challenges
8. Establish project plan baselines and document assumptions
9. Compile and challenge project schedules with the project team, manage timelines through critical path analysis, monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes
10. Manage project Budgets, Contract Milestones and Spend and provide updates on a monthly basis to the SVP of CMC.
11. Provide oversight and review of all relevant Analytical Development source documents for regulatory submission.
12. Develop and maintain project plans for internal and external analytical resources, timelines, and budgets
13. Build and maintain strong collaborations and relationships with external CDMOs, internal technical leads and project teams

Skills and Attributes

Physical Demands

Travel

Education and Experience

• PhD in chemistry, chemical technologies, or related area with 15+ years relevant experience in analytical development roles within the pharmaceutical industry
• Expertise in phase-appropriate small molecule analytical method development and validation
• Extensive knowledge of advanced analytical principles and theories; expertise in analytical laboratory techniques for drug substance and drug product and application of control strategies through all stages of development
• Expertise in all relevant Quality and Regulatory guidelines.
• Knowledge and experience of pre-development activities – pre-formulation, solid state, formulations for animal studies
• Demonstrated ability to set clear and measurable goals, managing tasks and resources
• Excellent written and verbal communication skills, organization, and planning skills and a high level of technical aptitude and creativity
• Ability to implement new technologies for development programs

Other Duties