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Head of Medical Safety and Pharmacovigilance – Woburn, MA

Reporting into the Chief Medical Officer, the Head of Medical Safety and Pharmacovigilance will be responsible for implementation, execution and management of Pharmacovigilance and risk management activities as part of the Company’s product development and commercialization strategy. This individual will be the senior leader in the Company responsible for product safety strategy and Pharmacovigilance, Medical Safety, risk management systems and activities. This is a highly visible role that will interface across all levels of management and functional areas and is responsible for establishment of procedures and processes for development of product safety profiles, including evaluation of safety data, identification of safety signals, signal investigation, development and management of the benefit-risk profile of all Replimune products and oversight of all safety operations functions and partner safety agreements. This individual will also serve as a member of the Chief Medical Officer’s (CMO) Leadership Team and interact cross-functionally with other team members in determining overall product objectives and strategy.

This individual will be capable of taking initiative, possesses excellent leadership and management skills, and supporting innovation and forward-thinking patient-focused decision-making.

Key responsibilities:

  • Oversees and directs all aspects of Medical Safety, Pharmacovigilance and risk management activities for all investigational and marketed products within the Company in accordance with all Company, local, regional and international standards
  • Actively participates in oversight of patient safety in all clinical trials in which the Company is a Sponsor or participates as a Partner
  • Designs, conducts and directs all Safety Surveillance and safety reporting activities for the Company using internal and external resources including vendors
  • Provides oversight and strategic direction for all vendors to ensure services are of the highest quality and compliant with regulatory standards
  • Negotiates contracts, interacts with and supervises staff, contractors, consultants and vendors for pharmacovigilance and Medical safety services
  • Responsible to Senior Management for communicating product safety information and updates to product safety profiles on an ongoing basis and in a timely manner
  • Is the Company leader responsible for analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders
  • Development of key standard operating procedures (SOPs), responsible, accountable, consulted and informed (RACI)s, workflows and processes necessary to ensure performance of all safety surveillance and medical safety functions throughout the product lifecycle
  • Interaction and partnering with leaders of Company Quality, Preclinical, Toxicology, Regulatory, Clinical Development and Clinical Affairs functions
  • Helps to build and directs, manages and oversees the team of Medical Safety and Pharmacovigilance professionals including Safety Physicians, Safety Scientists, PV Managers, the Qualified Person for Pharmacoviglance (QPPV) and others within the Department of Medical Safety and Pharmacovigilance for the Company
  • Participates in the establishment of Company-wide Product Safety Review Meetings, and directs and oversees product-specific Safety Review Meetings for detection, evaluation and management of emerging safety signals
  • Represents Safety at joint study-specific Company-investigator Safety Review Committee meetings
  • Represents Company Safety and Pharmacovigilance function to national and international Regulatory Authorities and directs responses to regulatory information requests in collaboration with Regulatory Affairs
  • Responsible for ensuring adherence to regulatory requirements for reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse drug reactions (ADRs), pregnancy and other emerging safety information to regulatory authorities for all Replimune products and clinical trials
  • Responsible for all Company safety-related Regulatory communications and periodic reporting in accord with regional regulatory requirements including development safety update reports (DSURs), periodic safety update reports (PSURs)/periodic benefit risk evaluation reports (PBRERs), IND updates, and regulatory filings of INDs, NDAs, and MAAs, in collaboration with Regulatory Affairs
  • Responsible for oversight and management of safety reporting sections of all Clinical study protocols, Clinical study Reports, Investigator Brochures, and for development of product-specific safety profiles and Risk Management Plans and related documents
  • Responsible for establishment and maintenance of systems for documentation of safety and pharmacovigilance activities including Pharmacovigilance Master File
  • Responsible for development and maintenance of product-specific Company core safety information and safety elements of product labeling
  • Represents Company and directs Medical Safety and Pharmacovigilance responses during regulatory inspections and audits Responsible for oversight and maintenance of all partner safety data exchange agreements (SDEAs) and contracts to ensure the timely exchange of safety information and reporting to regulatory authorities
  • Responsible for Company-wide training and inspection-readiness in matters related to Safety and Pharmacovigilance and Safety Operations
  • At direction of Company CMO and CEO, responsible for due diligence and other responsibilities as assigned

Educational requirements:

  • Doctoral degree in medicine or pharmacology required/highly desirable (MD, DO, PharmD or equivalent)
  • 10+ years of industry experience in safety and pharmacovigilance including at least 5 years of increasing responsibility in administrative and management roles
  • Expertise in safety signal detection and management, clinical safety assessments of individual cases and aggregate data, case processing and routine pharmacovigilance practices, including interactions with Regulatory Authorities
  • Expert knowledge and familiarity with FDA regulations, EU GVP and ICH standards for development and marketing of pharmaceutical products, Good Clinical Practice (GCP) requirements, and other applicable regulatory standards
  • Clinical experience strongly preferred

Experience and skill requirement:

  • Excellent problem-solving, collaborative skills including the ability to balance competing interests of multiple stakeholders and work towards achieving mutually satisfactory solutions
  • Ability to work in a dynamic, fast-paced environment and flexibility to handle conflicting obligations in a time-sensitive manner
  • Sound strategic evaluation, analytic and decision-making skills
  • Excellent written and verbal communication skills
  • Experienced at managing cross functional teams
  • Can work effectively in a matrix environment

EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.