- Perform medical review of ICSRs for assigned product(s) in clinical development or for marketed products
- Ensure that ICSRs contain accurate medical content through appropriate querying and obtained source data verification.
- Collaborate closely with Drug Safety staff providing medical expertise and guidance for proper gathering, evaluation, medical assessment, and follow-up of ICSRs.
- Review and/or Author an Analysis of Similar Events (ASE) for expedited cases.
- Identify clinically important cases and lead the discussion on such cases by liaising with the medical monitor of the respective clinical study to discuss next steps.
- Review global literature for assigned products for identification of ICSRs and assess their reportability.
- Contribute to aggregate safety data reviews, signal evaluation, interpretation and documentation for assigned project(s) or product(s)
- Provide medical input in the development and maintenance of RMPs for assigned product(s)
- Contribute to science sections of the aggregate reports for assigned product(s)
- Provide medical input for the Reference Safety Information (RSI) for assigned product(s)
- Contribute/lead, participate and support Benefit-Risk Team meetings for assigned project(s) and product(s)
- Provide safety input in study protocols, study reports or high-level summary documents for regulatory filings for assigned project(s) or product(s)
- Prepare and present safety data for Data Monitoring Committees for specified project(s) or product(s)
- No supervisory responsibilities.
- M.D. degree required and a minimum of 5 years of experience post-residency with at least 2+ years of clinical experience post-residency; or,
- Equivalent combination of education and experience.
- Completion of an accredited medical or surgical residency program is required. Board certification is preferred.
- High level of medical competence with an ability to balance this with industry standards.
- A minimum of 5+ years of experience in a medical review role in the pharmaceutical industry with a strong understanding of relevant regulatory requirements.
- Prior experience in Oncology is preferred.
- Significant clinical experience (~ 5 years) may compensate for shorter experience in pharmaceutical/biotech company
- Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices
- Demonstrated and excellent knowledge of relevant 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 good organizational and planning skills by managing time, workload and resources of a team
- Leads and manages a team to execute on team objectives that contribute to accomplishing common functional and departmental goals
- Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of team members and colleagues.
- Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships.
- Good interpersonal skills and demonstrable ability to bring differing views to develop 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.
- Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility
- Plans and executes multiple activities
- Considers alternative methods and contingency plans to avoid potential issues
- Designs and implements solutions to address project level challenges, taking into consideration the broader impact
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Pharmacovigilance Risk Management Medical Director - Alameda, United States - Exelixis
Description
SUMMARY/JOB PURPOSE:The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely with Drug Safety Operations staff (on medical aspects of ICSRs) and Clinical Development (medical ICSR discussion and follow-up, as well as safety surveillance). The role supports regulatory compliance with pharmacovigilance regulations, safety signal detection/management, and contributes to the overall benefit-risk management of Exelixis products.
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:
Education/Experience:
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.
#LI-MB1
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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $226,000 - $321,500 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.
