Safety Physician - San Diego, CA | Biospace
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Safety Physician

Samumed

Location:
San Diego, CA
Posted Date:
7/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Clinical Operations, Pharmacovigilance,

Job Description


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 osteoarthritis, androgenetic alopecia, tendinopathy, degenerative disc disease, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.

Job Description and Responsibilities:

Samumed is currently looking for a talented and experienced Safety Physician to join its team.  The Safety Physician will provide medical expertise to the safety and pharmacovigilance department, in both clinical trials and post-marketing settings.  S/he will contribute to the analysis, review and approval of Individual Case Safety Reports (ICSR) and Periodic Reports for marketed and investigational products. S/he will maintain active pharmacovigilance oversight for products, including accurate signal detection, and will provide safety/medical input for review of risk management.

Key Responsibilities:

•   Oversee and provide pharmacovigilance and safety management expertise to internal and external customers, across multiple programs at Samumed
•   Write protocol synopses, study protocols, INDs, DSURs, and CSRs
•   Develop and review dashboard of metrics for key safety surveillance activities
•   Conduct structured reviews of safety profiles of all products in development on an annual basis or otherwise required
•   Conduct review of final drafts of the annual safety reports/DSURs
•   Provide inputs to decisions related to recall of clinical supplies
•   Contribute to analysis, preparation, and development of Risk Management Plans (RMPs)
•   Provide oversight of existing RMPs, including an assessment of the significance of newly available data and the need for updates to such RMPs
•   Approve the RMP strategy, including elements that require strategic cross-functional input and alignment
•   Review safety concerns escalated from internal and external stakeholders, including the competent regulatory authorities
•   Review potential issues that could reasonably be expected to lead to an urgent safety measure or restriction in development drugs (including, but not limited to, premature termination or suspension of a trial), and provide recommendations for review and approved by the Senior Leadership Team
•   Review and communicate trending, signaling, and other safety-related issues originating from any source for the purposes of detecting and reviewing safety signals (e.g., change in frequency, nature, or severity of a safety-related issue) in a timely manner
•   Oversee the development and implementation of agreed-upon risk/issue mitigation actions
•   In addition, working with the Clinical Development and Operations function:
     o   Co-ordinate activities of the drug-development continuum, for all assets until the protocol is final for a given clinical trial
     o   Develop clinical concepts, protocol synopses, and final trial protocols
     o   Provide coordination and endorsement of clinical concept, development of protocol synopses and final protocols
     o   Assess operational feasibility of proposed clinical trials in the process of protocol development

Requirements


•   A doctoral-level degree in medicine or equivalent combination of education and experience
•   Clinical experience in the practice of medicine
•   5+ years’ experience in a Clinical Development and Operations environment and related therapeutic specialties required
•   Strong understanding of the use of medical terminology and of drug-names in multiple nations and environments
•   Proficient with Microsoft Office Suite (Word, Excel), databases, email, internet, and smart phones
•   Excellent verbal and written communication skills (proficient in English) as well as strong presentation skills
•   Ability to multitask under tight deadlines while providing attention to detail and high quality work in a dynamic environment
•   Ability to be flexible, adapt to change, work independently, as well as experience working in a matrix environment