Associate Director Pharmacovigilance Safety - Philadelphia, United States - Spark Therapeutics

Spark Therapeutics
Spark Therapeutics
Verified Company
Philadelphia, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description
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 unlock the power of gene therapy to accelerate healthcare transformation.

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


Primary Duties

Responsibilities

Clinical Development:

  • Represent PV during internal crossfunctional and external vendor meetings.
  • Independently provide input to clinical development planning activities.
  • Ensure consistent safety monitoring approach in line with industry standards.
  • Liaise with colleagues across functions to support collaborative workflows.
Clinical Safety

  • Proactively review clinical safety data to maintain current understanding of trial findings.
  • Responsible for performing database searches, and support safety lead physician analyzing/interpreting clinical trial data.
  • Support PV patient safety lead during crossfunctional document authorship (CSR, IB, protocol, ICF, etc.) including responses to health authority queries.

Pharmacovigilance:

  • Lead authorship of aggregate reports, exercising judgment in method selection and networking with crossfunctional stakeholders to ensure highquality and timely submissions.
  • Help perform indepth evaluation of safety data from multiple sources to support product safety surveillance and signal detection activities, partner queries, and health authority requests.
  • Support internal PV audits, regulatory inspections, updates to safety management plans, and Sponsor training materials.
  • Lead development and revision of PV SOPs, consulting with crossfunctional stakeholders and management to effectively guide decisionmaking.
  • Maintain a central repository of drug safety documents, including records of signal detection and other PV activities pertinent to regulatory inspections.
  • Collaborate with other functional areas to achieve business goals and objectives.
  • Foster Spark's Culture.
    Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations.
  • Emphasize to employees that "how" they achieve performance objectives is just as important as "what" they accomplish.

Education and Experience Requirements

  • Master's degree in a scientific discipline with 8+ years of PV or advanced degree in a scientific discipline (eg. Pharm.
D., Ph.
D.,) with 5+ years of relevant experience.

  • Knowledge of related disciplines preferred (eg. Epidemiology, biostatistics, or pharmacology)

Key Skills, Abilities, and Competencies

  • Advanced knowledge of ICH-GCP, cGMP, FDA, EMA, and other regulatory requirements pertaining to clinical trial conduct, adverse
- event assessment and reporting, risk management, and post-marketing safety requirements.

  • Ability to analyze and interpret medical and scientific data.
  • Demonstrated scientific writing skills.
  • Ability to manage multiple priorities and work in a flexible, dynamic, and fastpaced environment.
  • Excellent written and oral communication, project management skills, with the ability to work successfully across functions.
  • Ability to influence decision making and impact the future course of the organization.
  • Track record of building consensus and driving collaborative documents to completion.

Internal and External Contacts

Internal Spark Contacts:

  • Clinical Development
  • Clinical Operation
  • Regulatory Affairs
  • Biometrics
  • Corporate Quality Assurance
  • Medical Affairs
  • Crossfunctional teams
  • Legal

External Contacts**:
May serve as primary point of contact, supervise, and/or collaborate with external organizations.

  • Clinical CROs
  • License Business Partner(s)
  • PV Vendor(s)

Other Job Requirements:


  • Ability to work onsite in our Philadelphia office 3 days per week. Remote position with occasional travel to the office may be considered.
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