Manager, Pharmacovigilance Operations

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused

on improving quality of life increasing potential duration of life and resolving serious unmet

medical needs. At Summit we believe in building a team of world class professionals who

are passionate about this mission and it is our people who drive this mission to reality.

Summits core values include integrity passion for excellence purposeful urgency

collaboration and our commitment to people. Our employees are truly the heart and soul of

our culture and they are invaluable in shaping our journey toward excellence.

Summits team is inspired to touch and help change lives through Summits clinical

studies in the field of oncology. Summit has multiple global Phase 3 clinical studies

including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab

combined with chemotherapy compared to placebo plus chemotherapy in patients

with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who

were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab

combined with chemotherapy compared to pembrolizumab combined with

chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab

monotherapy compared to pembrolizumab monotherapy in patients with first-line

metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in

combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

Overview of Role:

The Manager Pharmacovigilance (PV) Operations will report to the Associate or Senior Director Pharmacovigilance Operations. The Manager PV Operations will support the PV team through study management for PV Operations including study start-up maintenance and closure; vendor oversight of ICSR case management submissions and archival; SAE Reconciliation; aggregate report submissions; cross-functional collaboration; and business partner management (if applicable). This position will also support PV Operations leadership via operational activities including but not limited to:

• Support the development of PV documentation (SOPs WIs SAE/pregnancy forms ICFs)
• Support the development of SMP (safety management plan)
• Assist in tracking and managing Protocol deviation CAPA and PV Training management
• Support Safety Science on signal detection risk management and literature search activities
• Communication with internal and external shareholders
• Support audits and inspections

Role and Responsibilities:

• Study Management:
  • Study start up:
    • Develop/oversee SAE / Pregnancy Reporting forms processes and/or Safety Management Plan.
    • Support development of Investigator Meeting (IM) and/or Site Initiation Visit (SIV) Training materials for PV Operations.
    • Oversee SAE Reconciliation Plan and SMP development.
  • Study Management:
    • Oversee ICSR and periodic report processing and submissions for assigned studies.
    • Represent PV Operations in cross-functional internal and external study level meetings.
    • Resolve study level issues pertaining to PV Operations.
    • Support the PV Operations Team in providing study specific metrics (KPIs and KQIs).
    • Oversee SAE Reconciliation for assigned studies.
  • Study Closeout:
    • Oversee completion/closure of all applicable ICSRs and their submissions.
    • Oversee safety document archival.
• Oversight of PV:
  • Support inspection readiness relating to PV activities.
  • Routine monitoring of compliance including monitoring of KPIs and KQIs to assess PV quality from CROs vendors external partners and internal stakeholders; oversight of case processing activities and submission of SUSARs; submission of aggregate reports (e.g. DSUR PSUR PADER 6MLL/3MLL); development and implementation of a master SMP; and oversight of external shareholders license partners and vendors through development implementation and compliance of Pharmacovigilance Agreements (PVAs) and/or Safety Data Exchange Agreements (SDEAs).
• Process development:
  • Assist in the development of PV Standard Operating Procedures (SOPs) and Working Instructions (WIs);
  • Assist in the review of cross-departmental documents where PV holds responsibility for a step in the process;
  • Support the maintenance of Regulatory Intelligence for regulatory requirements of Safety Reports by different Regulatory Authorities.
• Stakeholder collaboration:
  • Support Safety Science with signal management and literature search activities with internal and external stakeholders;
  • Support cross-functional teams in overall Safety Management and risk minimization measures in support of clinical development regulatory filings and safety reporting requirements;
  • Work with Quality Team to plan execute and report audits of vendors partners and CROs;
  • Work with Quality Team to support external audits and inspections.
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in a health related field (RN MSN MPH etc.)
• Minimum of 5 years of experience in PV in Biotech Pharma or a CRO.
• Prior experience working within a Safety Database (Argus ARISg etc.).
• Prior experience in Clinical Safety and Risk Management with an understanding of the various stages of the product life cycle.
• Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks.
• Ability to translate PV knowledge and expertise into action.
• Demonstrated ability to monitor multiple projects and actively track timelines.
• Knowledge of ICH guidelines relevant to PV and of global PV regulations such as FDA EMA MHRA Health Canada etc.
• Experience working with management and cross-functional stakeholders (e.g. Clinical Regulatory Quality) including an ability to influence without authority.
• Effective collaboration and interpersonal skills.

The pay range for this role is $122000-$143000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.