- 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 in association with lead candidate, 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.
- Provide support, as required, for licensing activities, regulatory authority inspections, and company audits.
- Participate as a PV expert in cross-functional team meetings, DMC meetings, investigator meetings, as applicable.
- Demonstrate knowledge of local and global health authority requirements.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.
- Collaborate with compliance and quality risk management function in relation to quality standards.
- 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.
- Experience in aggregate report preparation and review.
- Experience in cross-functional collaboration with clinical development, regulatory affairs, medical affairs, quality and legal counsel.
- Experience in people management, including vendor management and preferably with remote management experience too.
- Strong, effective organizational, facilitation, interpersonal and communication skills.
- Proficient with Microsoft Office Suite, mainly excel and power point or related software.
- Excellent English written and verbal communication skills.
- Travel national/international based on business needs.
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Director, Head Pharmacovigilance, Vaccine Safety - Boston, United States - HireMinds LLC
1 week ago
Description
Our vaccine client base in Boston, MA is looking to add a Director, Head Pharmacovigilance, Vaccine Safety to their team (CONTRACT/REMOTE) The ideal candidate will oversee signal and PV life-cycle management and will be involved in a broad variety of PV and clinical safety activities.
This contract role will be full-time/40 hours/week and may have the opportunity to turn into a permanent hire Initial contract is slated till mid-year / 3months and has the ability to be extended/turn perm, based on the organization's needs.
Responsibilities include but not limited to:
Requirements:
Travel:
