Medical Director, Pharmacovigilance Risk Management

Job Description

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.

Qualifications

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: 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)

SUPERVISORY RESPONSIBILITIES: May provide direction to other individuals. No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education: M.D. degree required Completion of an accredited medical or surgical residency program is required. Board certification is preferred. 5+ years of experience post-residency with at least 2+ years of clinical experience post-residency.

Experience: 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 solid tumor Oncology is required. Significant clinical experience ( 5 years) may compensate for shorter experience in pharmaceutical/biotech company

Knowledge/Skills: Familiarity with Drug Safety Databases (previous experience with Argus is a plus), data analysis tools, and document management systems Excellent teamwork/collaboration Strong interpersonal skills, including negotiation, influencing, coalition-building, motivating, empowering Excellent oral, written and presentation communication skills Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments Project management skills: Ability to manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure Able to think and act strategically, anticipate roadblocks and map out next steps Strong analytical, assessment and problem-solving skills Problem solving skills: demonstrates the ability to solve complex, difficult, and intractable problems; creates effective and innovative solutions Able to deal with ambiguity: regularly applies ingenuity to compensate without having the total picture Show composure: Effectively negotiates challenging situations and settles dispute equitably Strategic agility: anticipates future events accurately Drive for results: completes challenging assignments successfully and helps others to meet their goals Proficient in Microsoft office and safety database capabilities MedDRA knowledge Mentoring skills for junior staff

WORKING CONDITIONS:Development/Alameda: Environment: primarily working indoors, performing drug safety documentation work

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Additional Information

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.