Director, Pharmacovigilance

Company: Spero Therapeutics
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero's lead product candidate, Tebipenem HBr, is an oral carbapenem currently being evaluated in a pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infections. Spero is also advancing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero's third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections. We sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings. General Scope and Summary of Role Spero Therapeutics is looking for a collaborative, enthusiastic partner responsible for providing broad support of activities requiring clinical safety input for assigned products, pre- and post-approval. He/she will support periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. He/she will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives. What You'll Do

• Ensure that all pharmacovigilance obligations are fulfilled and that all the required PV activities are in line to support an assigned clinical trial or post marketing activity, and to ensure subject safety.
• Provide support to the Head, Pharmacovigilance to maintain pharmacovigilance expertise, and understanding of international safety regulations and guidelines, and global HA/ethics expedited and periodic submission requirements.
• Work with the Study Physicians and CROs to monitor and assess potential safety signals from ongoing clinical trials and post-launch safety surveillance data.
• Oversee clinical assessment of adverse events, SAEs, SUSARs and safety signals collected from clinical trials, and post-marketing surveillance in the assigned therapeutic area(s). Prepare summary reports for Safety Review Board meetings
• Assist with data analysis for responses to health authorities' questions and support preparation of Advisory Committee meetings.
• Responsible for signal detection and evaluation. Identify and implement proactive safety analysis strategies to further define the safety profile.
• Lead aggregate safety data review activities and coordinate safety surveillance activities.
• Prepare or review Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans in liaison with clinical development teams and CROs.--
• Logistical support to the Head, PV for medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
• Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
• Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
• Logistical support for Periodic Safety Reports (DSUR and PSUR), and line listings. What You'll Need
  • A collaborative individual with the organizational skills to coordinate the efforts of the Head of PV, Study Physicians, external safety vendor(s), and the internal Safety Review Board to ensure patient safety.
  • Extensive experience in patient safety/pharmacovigilance including applicable industry experience.
  • Minimum of 5 years' experience in Drug Safety/Pharmacovigilance or Medical Monitor experience.
  • Professional degree (RN, Pharm D) desired but not mandatory.
  • Adequate knowledge of GCP, ICH and Global regulations.
  • Experienced in the evaluation and interpretation of data.
  • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
  • Operational experience in production of core safety outputs
  • Experience and ability to develop and implement new standards and best practices. By joining our committed and highly motivated team, you will experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero's culture is one that emphasizes "servant leadership," or putting ego aside and working for the benefit of the team and our patients and values our colleagues' opinions and celebrates accomplishments in service of patients. What's your citizenship / employment eligibility?*

Keywords: Spero Therapeutics, Cambridge , Director, Pharmacovigilance, Executive , Cambridge, Massachusetts