Senior Manager, Pharmacovigilance Operations

Senior Manager, Pharmacovigilance Operations Location Menlo Park, CA or Remote Our Mission: To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs.
We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule taking advantage of cooperative binding between the two.
We initiated multiple phase-III clinical studies in the following Lung cancer indications: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”) Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”) Ivonescimab is an investigational therapy that is not approved by any regulatory authority.
It is currently being investigated in Phase III clinical studies.
Senior Manager, Pharmacovigilance (PV) Operations will report directly to the Senior Director, Pharmacovigilance Operations.
The Senior Manager PV Operations will support the PV team through PV vendor management, oversight of case processing/submissions, aggregate report submissions, and partner management (if applicable).
This role encompasses monitoring of PV Compliance and key performance indicators (KPIs) / key quality indicators (KQIs) through activities including, but not limited to: Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs) Development of SMP (safety management plan) 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 Key Responsibilities: Oversight of PV: Support of inspection readiness preparation and maintenance relating to PV activities; Support onboarding and training of new employees, and creation and maintenance of a PV Training Matrix for internal and external stakeholders; Routine monitoring of compliance including creation and 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: Actively support the development of PV Standard Operating Procedures (SOPs), and Working Instructions (WIs); Support the review of cross-departmental documents where PV holds responsibility for a step in the process; Support in the creation of PV CAPA process to identify, assess, address, and monitor non-compliance, including ensuring proposed corrective actions plans are executed and review process is in place for identifying trends; Support the development 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.
Minimum Requirements/Qualifications: Bachelor’s degree in a health related field (RN, MSN, MPH, etc.
) and a minimum of 5/8 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 both 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.
Proficient user of standard MS Office suite (e.
g.
, Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking, problem solving, ability to work independently.
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
Communicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demands.
Work in a fast-paced, demanding and collaborative environment 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 Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.
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 Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.