Assoc Director, Patient Safety Medical Device Safety at Gilead Sciences

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Dynamic and experienced individual with passion for patient safety
Strong strategic thinking, communication, and analytical skills
Broad pharmacovigilance (PV) and medical device/combination product experience
Enthusiasm for understanding business needs
Expertise in medical device/combination product safety oversight
Technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance, and trending/signal management

Responsibilities

Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products, and diagnostics
Review device cases/complaints to ensure accurate case processing and evaluation in compliance with regulatory requirements for safety reporting and Gilead standards
Collaborate closely with ICSR and Product Complaint teams to resolve issues, inconsistencies, or inaccuracies between the Global Safety database and Quality database
Develop training and standards for case processing and safety reporting
Contribute to medical device/combination product Post-Market Surveillance (PMS), including planning and report preparation
Support writing, review, and submission of applicable device contributions in aggregate reports (PSUR/PBRER, PADER)
Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets, including device complaints, device trending, and signal management for combination products
Provide device safety contributions and collaborate with PS Therapeutic Area leads in combination product development and clinical studies
Collaborate with cross-functional teams in device risk management activities, including identification and reduction of risks
Support activities for ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle, including compliant global processes for vigilance/safety reporting, post-market surveillance, trending of device complaints, risk management, and analysis of safety data sets
Drive strategies and ensure operational excellence through successful business partner collaboration

Skills

Key technologies and capabilities for this role

Patient SafetyMedical Device SafetyVigilance ReportingPost-Market SurveillanceRisk ManagementSafety Data AnalysisGlobal ComplianceDevice Complaints TrendingCombination Products

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require office work?

This information is not specified in the job description.

What key skills are needed for the Associate Director, Patient Safety Medical Device Safety role?

The role requires expertise in medical devices and combination products, strong strategic thinking, communication and analytical skills, broad pharmacovigilance (PV) experience, and enthusiasm for understanding business needs.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered.

What makes a strong candidate for this position?

A strong candidate is dynamic, experienced, passionate about patient safety, with expertise as a medical device/combination product expert, and skills in strategic thinking, communication, analysis, PV, and understanding business needs.

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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