Medical Director, Patient Safety & Pharmacovigilance (Office or Remote) in Brisbane, CA – reputed company, CA

Medical Director, Patient Safety & Pharmacovigilance (Office or Remote) - reputed company - Brisbane, CA - reputed company, CA - work from home job Company: reputed company Job reputed company: reputed company: The Medical Director, Safety and Pharmacovigilance will reputed company medical expertise across the growing Arcus clinical portfolio by supporting a reputed company of reputed company medical activities including the management of safety signal, risk management, and benefit-reputed company for the assets as reputed company as medical review individual case safety reports (ICSRs). This individual must effectively collaborate cross-functionally at reputed company reputed company of the organization as reputed company as with external Regulatory Authorities. This leader will report into the Sr. Medical Director for Safety and Pharmacovigilance. Responsibilities: • reputed company, contribute to, and reputed company the execution of the signal detection reputed company for the Arcus portfolio. • Coordinate cross-functional Safety Review Teams and Safety Management Committees. • Preparation and review of periodic aggregate reports (IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), EU renewal, etc.) • Review, contribute, and author as appropriate, relevant sections of the clinical trial protocols, the Investigator’s Brochure (IB), Company reputed company Data Sheet (CCDS), informed consent reputed company (reputed company) and other study specific documents to ensure alignment with the asset benefit-risk reputed company. • Leads the effort to create developmental risk management plans by seeking input from cross-functional stakeholders. • Provides strategic medical input into Regulatory Authority safety assessments and requests for information. • Prepare and review relevant sections of the Regulatory Authority filing and submission packets for Investigational New Drug (IND), New Drug Applications (NDAs), Marketing Authorization Applications, etc. • Participate in and reputed company input for Drug Monitoring Committees (iDMC), as applicable. • Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and/or journals. • Contribute, as appropriate, to the medical safety evaluation of reputed company for new business development opportunities (e.g., due diligence evaluations). Qualifications: • Education: Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) degree required. reputed company or hospital setting oncology experience preferred. • 3+ years’ relevant Safety experience required. Experience working in oncology and or early development are preferred but not required. • Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources reputed company the Safety department. • Demonstrated ability to work effectively in a dynamic, reputed company, cross-functional, and fast-paced team environment. • Excellent interpersonal, communication, analytical, and organizational skills. This role can be based at our reputed company or SSF/Brisbane, CA location or can be remote based. The anticipated salary reputed company for fully reputed company candidates applying for this position is $240,000 - $280,000 USD annually. This salary reputed company is an estimate of reputed company reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In reputed company to a competitive market-based salary, Arcus offers reputed company to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be reputed company here: reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. Arcus is committed to the reputed company of equal employment opportunity for reputed company and does not discriminate based on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets #LI-JC1 #LI-Remote Expected salary: Location: Brisbane, CA - reputed company, CA Job date: Sun, 10 Sep 2023 07:17:14 GMT Apply for the job now! Apply tot his job Apply To this Job