Medical Safety Operations Manager

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Medical Safety Operations Manager in Redwood City, California. This hybrid onsite and remote role will oversee and manage Medical Safety functional activities for all assigned clinical programs. If you are a career-focused professional, this is the opportunity for you.

Responsibilities

• Assist with authoring and updating clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports
• Manage PV CROs to ensure compliance with required timelines
• Direct Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies
• Share experience and expertise with medical safety team in other PV activities when needed
• Ensure potential issues are being communicated and resolutions are achieved in a timely manner
• Collaborate with other functional groups to achieve clinical program goals
• Represent Medical Safety in different cross-functional team meetings
• Verify timely set up of global safety reporting and safety database in assigned clinical programs
• Support the execution and maintenance of Safety Data Exchange/Pharmacovigilance Agreements with business partners
• Work with other functional groups in SAE reconciliation and SAE query resolution activities
• Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure compliance with global regulatory requirements

Experience

• Experience with safety reporting regulatory compliance and international safety reporting/regulations in clinical trials
• Demonstrated experience working with CROs/vendors and managing external resources
• Excellent written, interpersonal, and verbal communication skills
• Good attention to detail
• Knowledge of MS Office 365 (Outlook, Word, PowerPoint, Excel) and Adobe Acrobat
• Oncology experience preferred
• Experience working with global clinical trials, investigator-sponsored trials, compassionate-use programs, and business partnerships preferred
• Ability to exercise discretion regarding highly confidential internal/external communications
• Minimum of 3 years of pharmacovigilance operational activities experience required
• Strong ability to solve problems, multi-task, prioritize options, work independently, anticipate challenges, and execute assigned deliverables
• Ability to work in cross-functional team environments and with external vendors

EDUCATION

• Minimum of Bachelor’s Degree in a healthcare field required

To Be a Best-fit Your Strengths Must Include

• Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
• Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.

About Advanced Clinical

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available. 506588