Head of Drug Safety and Pharmacovigilance
Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Head of Drug Safety and Pharmacovigilance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees all medical pharmacovigilance activities including signal detection, safety review across trails, DSUR and annual report development across compounds, as well as single case review and development.
- Chairs the safety management team, which oversees safety monitoring for all compounds and characterizes the safety profile and risk-benefit evaluation for individual compounds in the company.
- Is responsible for determining optimal timing for yearly IB updates across compounds. May be responsible for managing and optimizing content of the yearly updates.
- Contributes to study design and protocol development, as well as the analysis and synthesis of trial data with specific attention to safety sections and benefit-risk evaluation.
- Manages and ensures the PV related operational activities.
- Provides medical oversight to contractors, consultants and non-physician team members involved in preparing varies written safety documents.
- Anticipates safety concerns and influences relevant functional teams to minimize/mitigate patient impact by active participation in the design of the study/clinical protocols.
- Contributes to the analysis and synthesis of trial data with special attention to safety sections and benefit-risk.
- Acts as a safety data characterization and benefit-risk assessment reviewer and contributor on NDA and MAA dossiers and labelling update.
- Reviews company’s partner study protocol design and other trial documents and provides medical input as appropriate.
- Provides input to business development regarding needs associated with licensing activities.
- Ensures compliant PV and appropriate processes are in place for the collection, collation, evaluation and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements.
- Ensures compliance with reporting requirements. Serves as primary liaison with QA during PV inspections and collaborates in preparation of responses to inspection observations.
- Ensures required outputs are available and accurate to support expedited/periodic reporting, signal detection, and regulatory queries and regulatory inspections.
- Provides identification and oversight of vendors.
- Oversees development, execution, and maintenance of Safety Data Exchange Agreements for all development, licensing, commercialization, and distribution partnerships to meet regulatory requirements and protect company assets.
- Leads the operations and strategy of the department. Alerts senior management to significant deficiencies in quality and compliance standards related to PV activities and ensures corrective/preventive actions are implemented.
- Manages and leads the PV team and ensures that a scalable and compliant quality and operations organizations is in place. Creates a culture surrounding leadership, innovation, and problem solving.
- Represents the company externally in the context of collaboration with business partners. Ensures the collaboration is medically sound, compliant with regulations and written agreements. Manages and maintains good working relationships with business partners.
- Is responsible for compliance with applicable GxP regulations in performing the functions of the job and attendance at annual GxP or other applicable regulatory training provided by the company.
- A Medical degree is required.
- Must have a minimum of ten years in the industry with 5 years in Pharmacovigilance, with prior oversight of PV compliance, quality and training, external contracts, and database systems.
- Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, the development and maintenance of SOPs and training programs, and PV systems/databases is required.
- Requires solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance and reporting to Health Authorities worldwide.
- Must have experience with pharmacovigilance inspections by major global Health Authorities.
- The ability to assess the evolving regulatory landscape, weigh possible courses of action, provide advice, and make decisions is required.
- Must understand a large-scale electronic data storage and retrieval system.
- Requires the proven ability to work well and effectively in a team environment. Demonstrated experience in building and maintaining strong long-term professional working relationships is required.
- Excellent interpersonal, communication, analytical, and organizational skills are required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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