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Head of Pharmacovigilance

Date: Dec 2, 2018

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

Summary

Reporting directly to the Chief Medical Officer, the Head of Pharmacovigilance has responsibility for setting the overall strategic vision for Safety and Pharmacovigilance. Responsibility starts with products in various stages of clinical development and follows them through their lifecycle and commercialization, to ensure Spark protects patients’ safety.

The Head of Pharmacovigilance will work closely with the senior leadership team, serve as Chair of the Safety and Pharmacovigilance Compliance Committees for oversight of safety related issues, and will partner cross-functionally with clinical, commercial, medical and regulatory organizations. This role will sit in Spark’s Philadelphia, PA headquarters.

He/she will be responsible for ensuring that pharmacovigilance systems and processes are in place for the evaluation and reporting of safety information, and other responses, to meet applicable global regulatory requirements for all products from development through post-marketing. This individual will provide expert guidance and decision-making and act as an internal point of contact for all matters relating to drug safety and pharmacovigilance, and will be the external liaison for global regulatory agencies and pharmacovigilance vendors. As Spark Therapeutics continues to grow and develop, the Head of Pharmacovigilance will help to shape the strategy and direction of the global drug safety function to meet the organizational needs and provide influence for overall R&D strategy.

 

Responsibilities

  • Lead all aspects of global drug safety activities and ensure that provision of a clearly defined safety strategy in the context of delivering the risk-benefit profile is established and communicated.
     
  • Ensure appropriate oversight of the emerging safety profile of the product including signal detection and evaluation, risk-benefit evaluation and risk management, and that all significant signals or safety issues are escalated and addressed appropriately.

 

  • Conceptualize and implement best-in-class global systems for the collection, collation, evaluation and distribution of safety reports, preparation and submission of aggregate reports, data management, signal detection and risk management.
     

 

  • Liaise effectively with other R&D leaders to ensure the smooth flow of safety data and prioritization of safety-related activities.
     
  • Contribute to the determination of any business risk related to the acquisition of new or existing products.
     
  • Interfaces externally with extensive vendors (Global Pharmacovigilance, CROs, Medical Information, etc.), external Key Opinion Leaders, investigators and study teams, independent researchers, consultants, scientific advisors and other key partners.

 

  • Responsible for establishing training protocols for overall pharmacovigilance and regulatory reporting.
     
  • Support the overall global infrastructure of PV risk management activities throughout product development, commercialization, and post-marketing commitments, and the development, implementation, revision and progress reports of risk management plans, as required by global health authorities.
     
  • Review and provide input on global Standard Operating Procedures (SOPs) and Work Instructions.
     
  • Provide oversight for the timely preparation of annual IND reports and aggregate safety reports, including PSURs, PBRERs, PADERs, and PBRERs.
     
  • Maintain expert knowledge of US REMS, PMR/ PMC, and EU RMP, PASS development.
     
  • Represent Spark in Regulatory Agency inspections and participate in regulatory agency meetings as required.
     

 

Qualifications

MD degree required.

Requirments

  • At least 10 years of experience in drug safety (both pre- and post-marketing) in a pharmaceutical or biotechnology company or CRO including at least 5 years of experience in a leadership role with responsibility for functional processes, systems and talent management
  • Thorough understanding of ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements pertaining to adverse event assessment and reporting, and post-marketing requirements for all markets where Spark products are distributed.
  • Proven track record in securing drug approval for biologic products in US, EU and other key international markets.
  • Able to interpret and apply medical information, instructions, policies, procedures and guidelines pertaining to drug safety; able to create and implement processes and structures to standardize pharmacovigilance function.
  • Strong technical writing skills with the ability to interpret and synthesize complex data
  • Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA.
  • Ability to work easily across all levels; comfortable dealing directly with the CEO and others at the C suite level and working collaboratively with cross-cultural and global teams.

 


Nearest Major Market: Philadelphia

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