Exel

Exec Medical Director, Pharmacovigilance Risk Management (PVRM)

Alameda, CA · Director

Sponsorship not specified$355k-$504kDetected 31 days ago

Data AnalysisProduct ManagementHRPerformance ManagementClinical TrialsClinical ResearchPharmacovigilanceResearchLeadershipCommunicationCollaboration

About the role

ESSENTIAL DUTIES AND RESPONSIBILITIES: The incumbent operates in a matrix environment within the global patient safety function and the broader development organization.
SUPERVISORY RESPONSIBILITIES: - Has supervisory responsibilities over direct reports - Significant cross-functional and cross-departmental interactions with clinical development, biometrics, medical affairs and regulatory affairs.
Selects communication method and medium appropriate to the message and the audience.

Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization.
Create appropriate safety data analysis strategies across clinical studies for a product.
Perform appropriate data interpretation on the performed safety analyses for a product.
Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
Lead the development of core safety documents, which characterize the safety profile of the product appropriately.
Lead proactive safety data reviews and anticipate safety concerns for the assigned product.
Develop risk management strategies and monitoring plans for risk management effectiveness for the product.
This role leads and mentors team members to proactively and successfully plan and manage key safety surveillance activities, safety analyses, risk management and safety document deliverables.
This role also engages and collaborates cross-functionally to execute on the corporate development strategy.

M.D. degree and a minimum of 10 years of post-residency experience
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.

At least 10 years of experience of pharmacovigilance experience or other relevant experience (e.g., Clinical Research) in a pharmaceutical/biotechnology company.
Prior project and team leadership/management experience is preferred.
Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.

Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices throughout the entire product lifecycle
Demonstrates advanced skill and keen insight in gathering, analyzing and applying key information to solve complex problems
Demonstrates strong organizational and planning capabilities by managing time, workload and resources of a function
Capable of strategically and proactively assessing workload, trends, tasks and priorities for cross-functional activity
Education/Experience:
M.D. degree and a minimum of 10 years of post-residency experience; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
3+ years of clinical experience post-residency
Board Certification (if US) preferred
Significant clinical experience may compensate for shorter experience in pharmaceutical/biotech company
Pharmacovigilance experience in Oncology is a plus.

The base pay range for this position is $355,000 - $504,000 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.
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
Lead the cross-functional Benefit Risk Team for the assigned product and escalate important safety updates to the Benefit Risk Executive Committee in a timely fashion.
Present safety data and provide safety expertise on the product during key meetings (e.g., with Health Authorities, Data Safety Monitoring Boards and Investigators).
Co-lead the benefit-risk assessment for the product with other functions.
Significant cross-functional and cross-departmental interactions with clinical development, biometrics, medical affairs and regulatory affairs.

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.

This listing is sourced directly from Exel's careers page and normalized into a canonical job model.