Associate Director/ Director Drug Safety and Pharmacovigilance (DSPV)

Job Description

Job Title:          Associate Director/ Director Drug Safety and Pharmacovigilance (DSPV)

Reports To:       Sr. Director of Drug Safety and Pharmacovigilance

Location:            Boston, MA

Position Summary:

A broad-based pharmacovigilance role including oversight of outsourced case processing activities, oversight of business partner safety activities, coordination of vendor/sponsor safety surveillance activities, participation in pharmacovigilance system and pharmacovigilance quality system buildout prior to filing for marketing approval

What makes this role special:

  • Seek to have a profound impact on young children and their families
  • Potentially be part of the first launch of a medicine for a rare pediatric liver disease
  • Work on a portfolio of multiple potential therapies
  • Gain a rare diversity of commercial experience
  • Develop strategy, as well as manage execution
  • Help shape the culture and future of an emerging biopharma with a big vision
  • Collaborate with a small, collegial team of good people
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment 

Responsibilities (may vary):

This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.

Key Duties and Responsibilities:

  • Provide sponsor oversight for outsourced drug safety and pharmacovigilance activities performed by third-party vendors. Outsourced activities include:
    • Case processing activities
    • Safety surveillance and signal detection activities
    • Periodic report (DSUR/PSUR) development and distribution
    • Maintenance of key documents and submission and activity tracking systems
  • Oversee business partner safety relationships as required
    • Collaborate with marketing partner(s) in the exchange of safety information, ensuring compliance with the safety data exchange agreement and pharmacovigilance regulations
  • Represent DSPV on clinical development teams
    • Review relevant sections of study budget
    • Oversee safety components of study setup, including safety database setup, CRF review and key document creation
    • Participate in the quality review of SAEs and SUSARs following data entry by vendor, including data accuracy, narrative quality, MedDRA coding, and appropriateness of follow-up safety queries.
    • Provide ongoing safety oversight as required, including support for database lock activities for SAEs
  • Participate in the buildout of the Pharmacovigilance System
    • Work with vendor in the development of the Risk Management Plan
    • Participate in the creation and maintenance of the Pharmacovigilance System Master file
    • Establish relationships with Qualified Persons for Pharmacovigilance
    • Participate in the buildout of Postmarketing adverse event collection
  • Participate in the development of the PV Quality System in preparation for filing for marketing approval
    • Participate in quality oversight ensuring department standards are met, including training requirements, monitoring vendor performance and implementing continuous improvement actions
    • Monitor compliance with regulations, PV agreements and internal SOPs
  • Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews
  • Participate in authoring and QC of periodic safety reports (e.g., DSUR, PSUR, PADER)
  • Works with QA department to maintain a state of high PV inspection readiness across all regions/countries.
  • Participate in internal audits and global regulatory inspections including MHRA/FDA/EMA etc. as a SME for specific PV topics and processes.
  • Contribute to formal responses to inspection and audit findings related to DSPV department.
  • Manage and develop DSPV staff as appropriate
  • Assist in performing additional ad hoc activities as assigned. 

Qualifications:

    Basic Qualifications:

  • Bachelor’s degree in nursing, pharmacy, or other health care-related profession or life sciences preferred or equivalent qualification/work experience.
  • Minimum of 7 years of experience in Drug Safety/Pharmacovigilance in a pharmaceutical industry setting or the equivalent.
  • Minimum of 4 years of experience working with third-party Pharmacovigilance vendors, CROs, and business alliance relationship management.

    Preferred Qualifications:

  • Global pharmacovigilance operations experience with marketed products and/or products in development.
  • Knowledge of relevant ICH, FDA, EMA, and PMDA Guidance and Regulations governing adverse event processing and reporting from clinical trials and/or post-marketing surveillance.
  • Experience working with safety databases and systems (Aris Global preferred)
  • Experience with MedDRA coding and data entry.
  • Experience with authoring periodic reports preferred but not required
  • Experience with safety surveillance and safety signaling activities preferred but not required
  • Proficient with Word, Excel and Powerpoint
  • Strong analytical and problem-solving skills with superb attention to detail.
  • Strong verbal, written technical communication and presentation skills.
  • Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
  • Proven ability to work within a cross-functional, matrixed team with the ability to manage multiple tasks with competing timelines.

JOIN ALBIREO

Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

All applicants should be legally entitled to work for any employer in the U.S.

Note to employment agencies: Please do not forward any agency resumes.  Albireo is not responsible for any fees related to resumes that are unsolicited.