Senior Director Pharmacovigilance and Drug Safety

Job Description

Job Title:             Senior Director Pharmacovigilance and Drug Safety

Reports To:          Chief Medical Officer

Location:               Boston, MA

Position Summary:

This position is responsible for building and leading the Global Pharmacovigilance Operations activities of the Medical Safety & Pharmacovigilance Department as well as strategic planning, roadmap development and execution of the Pharmacovigilance Operations Department structure, reporting and analytics requirements from the Global Safety database and PV systems and ensuring that Global PV regulatory requirements are met including the support of relevant PV Business Partners. Ensuring compliance with Global Pharmacovigilance and Regulatory requirements for adverse event management of medicinal products, both in development and post-marketing.

Essential Functions:

  • Sets the direction for Pharmacovigilance Operations activities at Albireo for ensuring compliance with all relevant Global PV Regulations and requirements for the processing of adverse events associated with investigational and marketed products
  • Establishes the direction, standards, and processes for supporting Pharmacovigilance Operations including the strategic planning, implementation, and management of activities
  • Responsible for managing internal and external staff allocated to Pharmacovigilance Operational activities including creating a highly efficient team across insourced and outsourced resources
  • Leads PV Vendor Oversight activities and directs the global oversight for management of Global Pharmacovigilance Operations Service Provider(s).
  • Leads innovation and strategy for the continuous enhancement of the PV Systems that are fully compliant with the applicable worldwide Health Authority PV regulations
  • Develops and implements an inspection readiness program in collaboration with other Albireo stakeholders
  • Leads the interaction with relevant internal or external functions for MSPV in inspections, and audits.
  • Oversees and ensures the Pharmacovigilance Operations business requirements are met including establishing and monitoring key quality and compliance metrics
  • Responsible for a compliant and quality execution of all operational activities related to case processing including timely submissions of expedited reports to the FDA & other Health Authorities. Identifies immediately deviations and applicable corrective and preventive actions to maintain compliance at its highest level.
  • Contributes to, drafts and implements department SOPs, Guidelines and Work Instructions related to the MSPV activities.
  • Supports signal detection activities, aggregate reports, benefit-risk assessment as required
  • Responsible for PV vendor contracts and the oversight of PV Agreements and Safety Data Exchange Agreements with vendors, partners and others

Qualifications:

  • Pharm D, RPh, RN, MD or other relevant training and education in the biomedical field with a minimum of 10 years of experience in the pharmaceutical industry and a minimum of 5 years in leadership positions in Medical Safety & Pharmacovigilance
  • Substantial experience in biotech/pharmaceutical industry with significant capability in product safety/pharmacovigilance for investigational and marketed products
  • Strong leadership and negotiation skills
  • Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally required
  • Ability to lead/supervise activities in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations required
  • Experience with activities associated with new product launch

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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.