Careers

Title: Director/Senior Director, Head of Pharmacovigilance Operations

Location: Waltham, MA

Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO.  The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections), which has completed phase III and zoliflodacin (targeting Neisseria gonorrhoeae) that is nearing phase III completion.  Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections.

This position will report to the Head of Regulatory and will be responsible for the leadership and co-ordination of pharmacovigilance activities for all development and marketed programs in compliance with regulatory guidelines.

  • Support and oversight of PV safety vendors, including development of PV agreements/ Safety Management Plan with safety vendors
  • Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
  • Ensure oversight of safety database for all products
  • Support and oversee PV safety data reconciliations
  • Oversee and support PV intake mailboxes and communications of Individual Case Safety Reports (ICSRs). Review incoming adverse events to determine action required
  • Support PV process for safety-related medical inquiries
  • Support inspection readiness activities and participate in regulatory inspections
  • Development and implementation of appropriate PV processes and systems
  • Support process for safety signal management activities, annual and aggregate reports (e.g. IB, PSURs, DSURs, Line Listings, RMPs) pooling scientific literature for safety information, and supporting Clinical Trial PV medical activities
  • Collaboration with cross-functional study teams to support risk management and pharmacovigilance for all ongoing clinical trials and post marketing (where applicable)
  • Support signal management process (ie, signal detection, signal tracking, signal documentation, facilitating meetings decisions regarding signals and safety risk, etc.) for assigned products. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
  • Collaborates with Clinical MDs for assigned investigational programs including clinical trial activities (protocol review, Informed consent form review, Clinical Study reports, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned
  • Support the ad hoc safety questions by internal and external stakeholders
  • Support and participate in Safety Review Team meetings
  • Contribute to health authority and other safety-related query responses
  • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
  • Ensure compliance with Risk Management policies and procedures
  • Develop and implement procedural documents, including SOPs, work instructions, forms and templates that support PV and signal detection processes

Qualifications

  • Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required. Master’s or Doctorate level degree in health care related profession preferred, but not essential.
  • Minimum 8 years pharmacovigilance operations or relevant experience, including at least 5 years on safety signal detection and aggregate safety reporting
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Knowledge of MedDRA terminology and its application
  • Excellent written and oral communication skills, strong attention to detail, and high-performance standards for quality
  • Ability to analyze, interpret, and summarize complex clinical and medical literature data
  • Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
  • Displays ability to understand established procedures and communicate those procedures to others
  • Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance

Possesses computer skills to support use of electronic systems and development of writing deliverables

 

Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538

Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off. 

Entasis is an equal opportunity workplace and participates in E-Verify.  We welcome diversity and are committed to creating an inclusive environment for all employees.   All employment is decided on the basis of qualifications, merit, and business need.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.

Entasis considers the health and safety of it’s employees and community a top priority.  To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation.  If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.

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