- Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
- Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds
- Review and perform clinical evaluation of individual case safety reports of SAEs and non-serious AEs occurring, including input for medical coding of events according to standard MedDRA terminology, as well as data cleaning.
- Prepare or review aggregate reports (PSURs, DSURs) and ad hoc safety reports.
- Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
- Ensure communication of all safety information that may impact the benefit-risk profile of assigned products to CMO/Senior Leadership.
- Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
- Provide patient safety input to the clinical development program for assigned development compounds, and represent PV on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable.
- Manage benefit-risk profile, oversee the preparation and maintenance of risk management plan (RMP) and risk evaluation and mitigation strategies (REMS)
- Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquires, MAAs, NDAs, and BLAs.
- Oversee the development and maintenance of the reference safety information (e.g., company core safety information DCSI / CCSI), IB.
- University degree (preferably MD or PhD), or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of general medicine.
- 5- 10 years in the pharmaceutical industry in pharmacovigilance or in a closely aligned field (e.g. regulatory affairs, clinical development, quality, preferably with at least 5 years' experience of working in global pharmacovigilance within the vaccines industry.
- Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required and ideally experience in filing vaccines marketing authorization applications.
- Strong investigational event and aggregate assessment/review/documentation skills.
- Extensive working knowledge of US/EU/APAC regulations and ICH guidelines
- Proven experience in communicating with the FDA, EMA, and other global health authorities.
- Sound working knowledge of MedDRA coding.
- Excellent understanding of pharmacovigilance-related information systems.
- Travel national/international based on business needs.
- This position is based in Boston, MA and may be performed partially remotely.
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Senior Director, Pharmacovigilance and Vaccine Safety - Boston, United States - HireMinds
Description
Director/Sr. Director, Pharmacovigilance, Vaccine Safety
Boston, MA
Our client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.
This is a full-time consulting role with the potential to convert to a direct hire down the road.
Responsibilities:
Education, Experience & Skills:
Travel, Physical Demands & Work Environment:
