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Pharmacovigilance Operations Jobs (NOW HIRING)

Zentalis

Associate Medical Director

San Diego, CA · On-site

The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to ...

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Pharmacovigilance Operations information

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$12

$49

$85

How much do pharmacovigilance operations jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for pharmacovigilance operations in the United States is $49.14, according to ZipRecruiter salary data. Most workers in this role earn between $38.46 and $55.53 per hour, depending on experience, location, and employer.

What is the difference between Pharmacovigilance Operations vs Pharmacovigilance Associate?

AspectPharmacovigilance OperationsPharmacovigilance Associate
ResponsibilitiesOversees safety data collection, processing, and reporting; manages PV systems and complianceSupports data entry, case processing, and documentation under supervision
Required CredentialsBachelor's degree in life sciences; relevant PV certifications often preferredBachelor's degree; entry-level PV training or certifications beneficial
Work EnvironmentTypically in pharmaceutical or biotech companies, regulatory agencies

Pharmacovigilance Operations involves managing safety data and ensuring compliance, often requiring more experience and specialized knowledge. Pharmacovigilance Associates support data entry and case processing, serving as entry-level roles. Both roles are essential in the PV industry, with Operations focusing on oversight and Associates on support tasks.

What is pharmacovigilance operations?

Pharmacovigilance Operations refers to the processes and activities involved in monitoring, detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. It ensures the safety of pharmaceutical products by collecting and analyzing data on side effects, coordinating case processing, reporting to regulatory authorities, and implementing risk management strategies. Professionals in pharmacovigilance operations play a key role in compliance with regulatory requirements and in protecting public health.

What are the key skills and qualifications needed to thrive in pharmacovigilance operations?

To thrive in Pharmacovigilance Operations, you need a background in life sciences or pharmacy, strong analytical abilities, and a solid understanding of drug safety regulations. Familiarity with safety databases like Argus or ArisG, and knowledge of regulatory systems such as FDA and EMA guidelines, are typically required. Attention to detail, effective communication, and the ability to work well under pressure are crucial soft skills for this role. These competencies ensure accurate adverse event reporting, regulatory compliance, and the protection of patient safety.

What are some common challenges faced in pharmacovigilance operations, and how can they be managed?

Pharmacovigilance Operations professionals often encounter challenges such as handling large volumes of adverse event reports, ensuring data quality, and meeting tight regulatory deadlines. Effective management typically involves strong organizational skills, attention to detail, and the use of specialized pharmacovigilance databases and tools. Collaborating closely with cross-functional teams—such as regulatory affairs and clinical teams—helps ensure accurate case processing and timely submissions. Continuous training and staying updated with evolving global regulations are also key to successfully navigating these challenges.
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Pharmacovigilance Operations jobs near you
Infographic showing various Pharmacovigilance Operations job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $102,217 per year, or $49.1 per hour.

Senior Director, Safety & Pharmacovigilance

Vaxcyte

San Carlos, CA • On-site

Full-time

Re-posted 14 days ago

Job description

Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
The Senior Director, Safety & Pharmacovigilance will lead the development and execution of a global safety and pharmacovigilance strategy aligned with Vaxcyte's corporate objectives and regulatory requirements. This executive will ensure scientific excellence, regulatory alignment, and operational rigor. The successful candidate will drive proactive risk management, foster a culture of innovation, and represent Vaxcyte in senior leadership and external forums.
Essential Functions:
Strategic Leadership & Vision
  • Serve as the primary safety representative in senior leadership forums, governance bodies, and external engagements with regulatory authorities and partners.
  • Champion a culture of safety, scientific integrity, and innovation across the organization. Anticipate and shape future strategic initiatives to ensure Vaxcyte remains at the forefront of safety science and regulatory compliance.

Safety Evaluation & Risk Management
  • Lead the identification, evaluation, and mitigation of safety risks across the product lifecycle, leveraging advanced analytics and real-world evidence.
  • Oversee comprehensive safety signal detection, validation, and management, ensuring timely escalation and resolution of potential safety issues.
  • Drive the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.
  • Provide expert oversight for safety data review, including aggregate analyses, periodic safety reports (DSURs, PSURs), and responses to regulatory queries.
  • Ensure robust safety surveillance through continuous monitoring of emerging safety data from clinical trials, post-marketing sources, literature, and external databases.

Pharmacovigilance Operations & Compliance
  • Oversee global PV systems and processes, including case processing, aggregate reporting, ensuring compliance with international regulations (FDA, EMA, PMDA, etc.).
  • Lead safety-related elements of inspection readiness and manage responses to audits, regulatory inquiries, and corrective action plans.
  • Develop and Maintain SOPs, safety governance frameworks to ensure operational excellence and regulatory compliance.
  • Stay abreast of evolving global safety regulations, guidelines, and best practices, proactively updating Vaxcyte's policies and procedures

Team Leadership & Development
  • Build, lead, and mentor a high-performing team, fostering a culture of accountability, collaboration, and continuous learning.
  • Provide strategic guidance, career development, and performance management for team members, ensuring the team's growth and success.
  • Drive organizational efficiency through effective resource management, outsourcing, and alliances.

Cross-Functional & External Collaboration
  • Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to ensure integrated safety oversight and seamless execution of safety strategies.
  • Collaborate with external partners, CROs, and affiliates, managing PV vendors and pharmacovigilance agreements, as needed to ensure consistent safety practices, reporting, and compliance across all programs.
  • Represent Vaxcyte at external meetings with regulatory authorities, partners, and clinical investigators, advocating for patient safety and Vaxcyte's scientific leadership.

Requirements:
RN, PharmD, PA or NP, or equivalent preferred with a minimum of 10 years of experience; Bachelor's degree in healthcare field or related with 14 years of experience will be considered. 8+ years of progressively increasing leadership responsibility within Safety Science or related field required. Other combinations of education and/or experience may be considered.
  • Proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within cell/gene therapy or advanced modalities.
  • Expertise in safety signal detection, risk management, and benefit-risk assessment, including interactions with regulatory authorities.
  • Strong analytical, strategic thinking, and communication skills; ability to influence at all levels of the organization.
  • Demonstrated ability to lead cross-functional teams and drive organizational performance.
  • Experience with safety databases (e.g., ARGUS, ARISg).
  • Substantial experience specifically in vaccine safety science is required; experience spanning both development-stage and marketed vaccines strongly preferred.
  • Demonstrated track record managing global regulatory PV submissions and health authority interactions (FDA, EMA, and at least one additional major health authority).
  • Prior experience building or scaling a pharmacovigilance function preferred.

Core Competencies:
  • Expert-level knowledge of global PV regulations and guidelines (21 CFR 312/600, ICH E2A-E2F, GVP modules, WHO guidelines).
  • Deep familiarity with Brighton Collaboration case definitions and AEFI methodology.
  • Proficiency with pharmacovigilance safety databases (e.g., Veeva Vault Safety, Argus, ARISg) and signal detection tools.
  • Strong understanding of epidemiological study design, including vaccine effectiveness and safety studies in real-world settings.
  • Experience with VAERS, Vaccine Safety Datalink (VSD), and/or similar post-market vaccine surveillance systems a significant advantage.

Reports to: Sr. Vice President, Clinical Development
Location: San Carlos, CA/Remote
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 2-3 days per week onsite)/Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $285,000 - $333,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Equal Opportunity
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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