NO C2C

NO C2C, NO 3rd parties, NO relocation candidates considered

Sr Director of Medical Safety (Operations)

Location: Foster City, CA.

(requires on-site time) MUST BE LOCAL CANDIDATES - relocation candidates will not be considered

Contract length:

6 months to start - possibility of contract to hire.

Compensation:The estimated pay range for this position is

$120/Hr. - $135/Hr. and is an Exempt role . Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location.

Position Summary:Milestone is seeking an Sr Director of Medical Safety Science. The ideal candidate will have experience in and perform multiple activities related to ICSR medical review, safety data review, document review, signal detection and validation, authoring of aggregate reports and participating in multidisciplinary meetings. Successful candidate will report to VP., Medical Safety.

QUALIFICATIONS

Education/Experience:PharmD degree is required

(coursework in clinical research preferred).Minimum 7-10 years pharmaceutical or CRO experience in a clinical trial or post-marketing setting,

5 years in a drug safety and pharmacovigilance roleExperience in medical review of ICSRs and safety surveillance activities (which includes but not limited to signal detection activities)Experience in AE and medical history coding review is required. MSSO-trained and UMC trained preferredSafety database and data entry experience preferred (Understands safety database structures and is familiar with data retrieval tools.)

Knowledge, Skills and Abilities:Excellent interpersonal and communication skills, both written and oralUnderstanding of medical terminology and the ability to summarize medical information is preferredAttention to detail and good organizational skillsThe ability to assess data and understand the medical/safety implications.Work within a matrix environment and interact/communicate effectively across various levels within the organization when needed.Team player but can work independently.

Job functions/responsibilitiesConduct Sponsor oversight, medical review and assessment of ICSRs both in post-marketing and clinical trial setting.Generate outputs from the Safety Database as needed for aggregate reports and ad hoc requestsPerform coding review of adverse events and medical history in the clinical database for all client products and studiesAuthor aggregate safety reports such as the DSUR, PADER, PSUR, etcRepresent Medical Safety Science in all clinical study team meetings for all Mirum productsReview and develop Medical Safety Science SOPs and Work Instructions.Contribute to the development of risk management plans and REMs if needed.Support safety surveillance/pharmacovigilance activities such as signal detection and validation, Safety Review Team meetings (SRT), and Global Safety Committee (GSC) meetings. This includes Signal monitoring/ tracking, scheduling of SRT and GST meetings, drafting of signal detection reports.Review and revise medical safety science-related sections in study protocols, periodic reports, and Regulatory Agency submission documents.Review revise SMPs, SDEAs, applicable SOPs and related forms from a Medical Safety Science perspective.Works closely with Medical Safety Operations to provide medical input on an as needed basisReview and assess literature search resultsSupports activities related to PV-specific inspection readiness by creating procedures and processes for Safety Science activities

Benefits:We offer comprehensive benefit options which vary depending on role, location, and employment type. Benefit options may include Medical, Dental, Vision, 401(k), Life Insurance, Short-Term Disability, Long-Term Disability, Flexible Spending Accounts, Parental Leave, Paid Time Off, and Holidays. The Talent Acquisition Partner can share more details about compensation or benefits for the specific role during the hiring processby Jobble #J-18808-Ljbffr

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