Senior Director of Pharmacovigilance and Risk Management
5 days ago
At BioPhase, we are seeking a highly experienced Senior Director of Pharmacovigilance and Risk Management to lead our efforts in ensuring the safety and efficacy of our products. This is a critical role that requires a deep understanding of regulatory requirements and industry standards.
Key Responsibilities- Develop and Implement Risk Management Strategies
Lead the creation and management of an advanced system for detecting, assessing, and minimizing risks across our product portfolio.
Collaborate with Cross-Functional TeamsWork closely with internal safety and risk committees, as well as external partners, to ensure that all risk management activities comply with relevant international regulations and guidelines.
Support Regulatory SubmissionsContribute to the development of regulatory submissions, including applications for marketing authorization and new drug/biologic licenses.
Manage Safety-Related CommitteesOversee the development of risk management strategies, including REMS, when necessary, and ensure effective delivery of these strategies.
Provide Expert Safety AnalysisCollaborate with stakeholders to prepare periodic safety reports and ensure accurate data analysis.
Direct and Collaborate on Risk Management PlansWork with safety physicians to produce and manage safety discussion documents and track safety signals.
Provide Internal Expertise in EpidemiologyCollaborate with other departments on relevant projects, including clinical trial planning and epidemiological research methods.
Support Health Authority Safety Data RequestsContribute to manuscript preparation for publication and advise on the identification and assessment of safety risks.
Qualifications and Experience- A Master's Degree in Public Health or a related field is required, with 10 years of progressive experience in applied epidemiology within a regulated biotech or pharmaceutical industry, or a PhD with 4 years of similar experience.
- Prior experience in drug safety and risk management is strongly preferred.
- Expertise in regulatory requirements and pharmacovigilance is essential.
- Proficiency in data analysis and experience with publishing research and presenting at scientific meetings is highly desirable.
- Must be skilled in MS Office and familiar with standard pharmacovigilance tools like Argus and Arisg.
- Experience with safety signal management tools such as Empirica, Topics, or Spotfire is preferred.
- Excellent written and verbal communication skills, with the ability to clearly convey findings and recommendations.
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