Manager / Senior Manager, Drug Safety & Pharmacovigilance
Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com).
Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer.
Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, Alzheimer’s disease, androgenetic alopecia, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
Samumed is looking to add a highly motivated Manager or Senior Manager, Drug Safety & Pharmacovigilance (DSPV) to its DSPV team. This position will report to the Vice President (VP) of DSPV. This position will provide, under the leadership of the DSPV head, adequate oversight for all DSPV activities for all Samumed-sponsored clinical studies. He/she will assist the head of DSPV and DSPV physicians to perform aggregate safety reviews, periodic safety signaling, as well as perform individual and aggregate case review and case management activities in collaboration with Samumed’s external partners. This is a full-time position, based at Samumed’s San Diego headquarters. Job title dependent upon experience level.
Specific responsibilities of the position include:
- Participating in protocol (safety sections) and informed consent form (ICF) development
- Participating in the preparation of data for the collection and ongoing monitoring and surveillance activities of safety information in Samumed clinical trial protocols
- Participating in preparation of study specific plans and forms to ensure that adequate safety information is collected, processed, and provided to study participants
- Participating in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports (CSRs)
- Ensuring compliance with worldwide regulations for DSPV
- Monitoring activities of CROs/business partners to ensure adherence and compliance with applicable Safety Monitoring Plans, other study plans, and contractual agreements
- Collaborating with the Medical Directors, as well as Clinical Development Operations, Regulatory Operations, and vendor’s clinical staff providing medical and/or monitoring support for ongoing clinical trials to ensure integration of safety data collection, review, processing, and reporting
- Participating in the cross-functional program team meetings and safety oversight meetings that manage the operational aspects as well as the overall benefit/risk profile of the compound
- Contributing to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, through the preparation of reports and data outputs and by ensuring prompt assessment of safety signals
- Collaborating with safety physicians and drug safety head, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing the safety data outputs
- Contributing to preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports such as IND Safety Report, Development Safety Update Reports (DSURs), and SUSAR listings in collaboration with safety physicians and external safety vendor
- Acting as “drug safety database super user” for the Samumed Global Safety Database (GSDB) in collaboration with, and providing oversight to, the GSDB hosting provider and DSPV vendors
- Collaborating with clinical teams in developing data quality standards for clinical studies, ongoing data review and query follow up, and vendor oversight
- Supporting the completion of CSRs by reviewing safety data, patient narratives, and safety sections of the documents.
- Contributing to the preparation for Data Safety Monitoring Board meetings.
- Leading PV inspection readiness in collaboration with the head of safety and QA, and coordinating global inspection readiness activities for PV inspections of Samumed products
- Assisting the head of DSPV in the preparation, facilitation, and documentation of safety governance meetings
- Providing Safety Reporting training at investigator meetings as needed
- Master’s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience; nursing degree or pharmacy degree preferred
- 5 years’ experience in pharmacovigilance operations in the pharmaceutical industry.
- Prior experience contributing to protocol, IB, and ICF development/updating
- Prior experience contributing to the safety sections of various reports
- Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance
- Experience working with, and providing oversight to PV vendors
- Working experience with safety databases (Argus) and signaling tools
- Working experience and/or interest to act as drug safety database super user for Samumed global drug safety database (GSDB) in collaboration with, and providing oversight to, the GSDB hosting provider
- Experience in data outputs preparation for performing drug safety periodic reviews
- Willingness to work hands-on in a fast-paced work environment
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