Senior Medical Director, Patient Safety & Pharmacovigilance (Office Or Remote)

7+ years

$280,000 - $350,000 USD annually

Remote, USA

10 July 22, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Medical Director, Patient Safety & Pharmacovigilance
Location: Hayward or Brisbane, CA (preferred) or Remote
Salary Range: $280,000 - $350,000 USD annually

About the Role:

The Senior Medical Director, Patient Safety & Pharmacovigilance at Arcus Biosciences will lead the safety and pharmacovigilance efforts across our expanding oncology portfolio. This role involves managing safety signals, developing risk management strategies, and ensuring robust benefit-risk assessments for our assets. The ideal candidate will possess extensive experience in oncology safety and demonstrate the ability to work effectively with cross-functional teams and external regulatory authorities. Reporting to the Head of Safety, this leader will directly oversee Safety Physicians and Safety Scientists.

Responsibilities:

Develop and oversee the execution of signal detection strategies for the Arcus portfolio.
Prepare and review periodic aggregate reports including IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and EU renewals.
Review and contribute to clinical trial protocols, Investigator’s Brochures (IB), Company Core Data Sheets (CCDS), informed consent forms (ICF), and other study documents to align with asset benefit-risk profiles.
Lead the creation of developmental risk management plans by gathering input from cross-functional teams.
Provide strategic medical input into safety assessments and regulatory authority inquiries.
Prepare and review sections of Regulatory Authority submissions such as INDs, NDAs, and Marketing Authorization Applications.
Participate in and contribute to Drug Monitoring Committees (iDMC), as applicable.
Contribute to scientific publications and presentations for meetings and journals.
Support medical safety evaluations for new business development opportunities, including due diligence.
Recruit, hire, mentor, and manage direct reports, including conducting performance evaluations.

Qualifications:

M.D. or D.O. degree required; experience in oncology within an academic or hospital setting preferred.
7+ years of relevant experience as a Safety Physician, with a preference for oncology experience involving NDA and BLA submissions.
Proven ability to create, evaluate, and maintain effective processes and implement systems to optimize resources within the Safety department.
Demonstrated success in a dynamic, fast-paced team environment.
Strong track record in building and leading high-performing teams.
In-depth knowledge of global pharmacovigilance regulations (EMA, FDA, PMDA, Asia-PAC, ICH).
Excellent people and project management skills with a focus on coaching and mentoring.
Outstanding interpersonal, communication, analytical, and organizational skills.

Additional Information:

Arcus Biosciences offers a competitive salary based on experience and qualifications, stock program participation, performance-based bonuses, and a comprehensive benefits package. For more details about our total rewards program, visit Arcus Careers.

Equal Opportunity Employer:

Arcus Biosciences is committed to providing equal employment opportunities to all employees and applicants. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. We are dedicated to creating a diverse and inclusive environment where everyone can thrive. EOE/AA/Vets.

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Senior Medical Director, Patient Safety & Pharmacovigilance (Office Or Remote)

Job Description

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