Associate Director Pharmacovigilance Safety Scientist

3 weeks ago

Philadelphia, United States Spark Therapeutics Full time

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

Reporting to the VP Patient Safety & Pharmacovigilance ("PV"), the Associate Director, PV Safety Scientist will provide scientific expertise across clinical development programs The selected individual will collaborate closely with the PV patient safety lead to support candidates/products in various stages of clinical development and commercialization. This role will be a key member of the PV team, and will be aligned to the strategy, goals, and objectives of the PV function. This role will regularly collaborate across functions and will represent PV in both internal meetings and external meetings with business partners. Will develop and refine PV processes, apply innovative solutions to problems, and ensure consistency with industry standards and organizational objectives.

Responsibilities

Clinical Development:

* Represent PV during internal cross-functional 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 cross-functional 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 cross-functional stakeholders to ensure high-quality and timely submissions.
* Help perform in-depth 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 cross-functional stakeholders and management to effectively guide decision-making.
* 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 fast-paced 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
* Cross-functional 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.



Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $152,600 to $229,000.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

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