Sr Pharmacovigilance Risk Management (Pvrm) Medical Director

SUMMARY/JOB PURPOSE: The Senior PVRM Medical Director is responsible for global oversight and management of all medical safety aspects for aggregate data on Exelixis product(s) during clinical development and following marketing authorization. The incumbent directs the Exelixis safety strategy and characterization through appropriate signal management, safety analyses and safety data descriptions in appropriate regulatory documents for the assigned product(s). Additionally, this role develops relevant risk management strategies for specified product-related risks. This position collaborates cross-functionally and escalates new safety findings through the corporate safety governance model.
Essential Duties And Responsibilities: This role operates in a matrix environment within the drug safety function and cross-functionally with other departments. Responsibilities for this position include:
Lead the safety strategy for all medical activities on aggregate data for assigned marketed and/or investigational Exelixis product(s).
Lead the cross-functional Benefit Risk Team for the assigned Exelixis product(s) and escalates important safety updates to the Benefit Risk Committee in a timely fashion.
Develop and maintain the strategy for ongoing signal detection across available data sources to further define the safety profile for assigned Exelixis product(s) during clinical development and in the post-marketing setting.
Lead the creation and maintenance of the Company Core Safety Information and ensure that risks are appropriately characterized and communicated in product labels for the assigned Exelixis product(s).
Provide pharmacovigilance and risk management expertise for the assigned Exelixis product(s) to internal and external customers.
Lead the safety strategy for clinical development documents and regulatory filing documents for the assigned Exelixis product(s).
Lead responses to safety questions from regulatory authorities, ethics committees, investigators and other external parties for the assigned Exelixis product(s).
Lead proactive safety data reviews and anticipate safety concerns for the assigned Exelixis product(s).
Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the assigned Exelixis product(s).
Present safety data and provide safety expertise on the assigned Exelixis product(s) during key meetings (e.g. with Health Authorities, Data Safety Monitoring Boards and Investigators).
Develop risk management strategies and monitoring plans for risk management effectiveness for the assigned Exelixis product(s).
Co-lead the benefit-risk assessment for the assigned Exelixis product(s) with other functions.
Supervisory Responsibilities: None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: M.D. degree required; Board Certification (if US) preferred and a minimum of 8 years of experience post-residency with at least 3+ years of clinical experience post-residency; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job: At least 7 years of pharmacovigilance experience or other relevant experience (eg Clinical Research) in a pharmaceutical/biotechnology company.
Pharmacovigilance experience in Oncology is a plus.
Prior experience in a similar role in a global environment is preferred.
Significant clinical experience (~ 7 years) may compensate for shorter experience in pharmaceutical/biotech company
Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.
Knowledge/Skills: Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices
Demonstrated and excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments
Demonstrates advanced skill and keen insight in gathering, sorting and applying key information to solve problems
Demonstrates strong organizational and planning capabilities by managing time, workload and resources of a function
Leads and manages a functional area within a department to execute on team functional objectives that contribute to accomplishing common functional and departmental goals
Demonstrates high standards of verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents to audiences within and outside Exelixis.
Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships.
Strong interpersonal skills and skilled at effectively resolving challenges by developing an agreed upon resolution
Develops procedures, tasks and tools. Trains staff on departmental products, tools and data sources. Develops and maintains knowledge of cross-functional products, tools and data sources. Mentors junior team members. Contributes to performance reviews and professional development plans of team members.
JOB COMPLEXITY: Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity
Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues
Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact
Engages, influences and collaborates with stakeholders on cross-functional projects
Working Conditions: Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $270,500 - $384,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.