Company: Spero Therapeutics
Posted on: April 8, 2021
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
- 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
- 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
- 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
- Operational experience in production of core safety
- 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
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