Director Drug Safety Big Pharma – San Francisco, CA

Are you a seasoned drug safety expert with a passion for safeguarding patient health and ensuring regulatory compliance? We are seeking a Director of Drug Safety to lead the pharmacovigilance and safety monitoring efforts for a leading pharmaceutical company based in San Francisco, CA. This is a unique opportunity to shape drug safety strategy, enhance risk management processes, and influence the development of innovative therapies that improve lives worldwide.

Drive Drug Safety Excellence at a Leading Pharmaceutical Company

Join a top-tier Big Pharma organization in San Francisco as the Director of Drug Safety, where you will spearhead global safety operations and collaborate cross-functionally with clinical, regulatory, and medical affairs teams. The ideal candidate will possess deep expertise in pharmacovigilance regulations, strong leadership capabilities, and a proven track record of implementing safety surveillance programs that uphold the highest standards of patient care and compliance. If you excel in a complex, fast-evolving environment and are committed to advancing drug safety, this role offers a compelling platform to make a significant impact.

Key Responsibilities of the Director Drug Safety – Big Pharma

Strategic Drug Safety Leadership: Develop and execute a comprehensive pharmacovigilance strategy that aligns with global regulatory requirements and corporate goals. Drive continuous improvement in drug safety processes to ensure patient protection and support product lifecycle management.

Safety Surveillance & Risk Management: Oversee the collection, evaluation, and reporting of adverse event data. Implement robust risk management plans and safety signal detection methodologies to proactively identify and mitigate safety risks associated with pharmaceutical products.

Regulatory Compliance & Reporting: Ensure full compliance with global drug safety regulations, including FDA, EMA, ICH, and other health authorities. Lead timely and accurate safety reporting, including Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs).

Cross-Functional Collaboration: Partner closely with clinical development, regulatory affairs, medical affairs, and quality teams to integrate safety data across functions and support regulatory submissions, labeling updates, and risk communication.

Team Leadership & Development: Build, mentor, and lead a high-performing drug safety team. Foster a culture of accountability, continuous learning, and collaboration to meet evolving safety challenges in a dynamic pharmaceutical environment.

Safety Data Systems & Technology: Oversee the implementation and optimization of safety databases, signal detection tools, and pharmacovigilance technology platforms. Drive automation and data analytics initiatives to enhance safety monitoring efficiency and quality.

Stakeholder Engagement & Communication: Act as the primary drug safety liaison for internal stakeholders and external partners, including regulatory authorities, clinical sites, and vendors. Deliver clear, data-driven safety updates and risk assessments to senior leadership and decision-makers.

Inspection Readiness & Audit Management: Prepare for and lead pharmacovigilance inspections and audits. Ensure that drug safety processes, documentation, and training meet internal standards and regulatory expectations to mitigate compliance risks.

What the Client is Looking for in You

As the Director of Drug Safety in a leading Big Pharma company, the client is seeking a highly experienced and strategic pharmacovigilance leader who is passionate about patient safety and regulatory excellence. You should be a proactive, detail-oriented professional who thrives in complex, fast-paced environments and is committed to advancing drug safety through innovative and compliant approaches.

Proven Expertise in Drug Safety and Pharmacovigilance

The client is looking for a seasoned drug safety expert with extensive knowledge of global pharmacovigilance regulations and hands-on experience managing safety data for pharmaceutical products. You should have a strong track record of leading safety surveillance, risk management, and regulatory reporting programs that ensure patient protection and compliance.

Strategic Vision and Risk Management Acumen

You must demonstrate the ability to develop and implement forward-thinking safety strategies that mitigate risks throughout the product lifecycle. The ideal candidate will excel in interpreting safety data, anticipating emerging safety signals, and making informed decisions that support regulatory submissions and business objectives.

Strong Regulatory and Compliance Knowledge

A deep understanding of FDA, EMA, ICH guidelines, and other relevant global regulatory frameworks is essential. The client values a leader who ensures full compliance with all pharmacovigilance obligations while preparing the organization for audits and inspections with rigor and transparency.

Exceptional Leadership and Team Building Skills

The client seeks a Director who can build and inspire a high-performing drug safety team. You should foster a culture of accountability, continuous learning, and collaboration, attracting top talent and empowering your team to excel in a challenging environment.

Effective Cross-Functional Collaboration

You will be expected to work seamlessly with clinical, regulatory, medical, and quality teams. The ability to communicate complex safety information clearly to diverse stakeholders and support integrated decision-making is critical to success.

Data-Driven and Technology-Savvy

The ideal candidate embraces innovation by leveraging advanced safety data systems, automation, and analytics to enhance pharmacovigilance efficiency and accuracy. You should be comfortable leading technology adoption initiatives that drive continuous improvement.

Strong Stakeholder Communication and Influence

The client values a Director who can serve as a trusted safety advisor to senior leadership, regulatory authorities, and external partners. Your ability to present clear, data-backed safety insights and foster transparent communication will be key to building confidence and support.

FAQs About the Role – Director Drug Safety – Big Pharma

1. What are the key responsibilities of the Director of Drug Safety in this role?

As the Director of Drug Safety, you will be responsible for overseeing global pharmacovigilance activities, ensuring compliance with regulatory requirements, managing safety data collection and analysis, and leading risk management initiatives. You will collaborate with clinical, regulatory, and medical teams to ensure patient safety and support product lifecycle management.

2. What qualifications and experience are required for this position?

The ideal candidate should have extensive experience in pharmacovigilance or drug safety within the pharmaceutical industry, including knowledge of global regulatory frameworks such as FDA, EMA, and ICH guidelines. Proven leadership skills in managing drug safety teams and processes are essential. Advanced degrees in pharmacy, medicine, life sciences, or related fields are highly desirable.

3. What leadership qualities are essential for this role?

The client seeks a proactive and strategic leader who can inspire and develop a high-performing drug safety team. Strong communication skills, regulatory expertise, analytical thinking, and the ability to collaborate across multiple departments are critical. You should be adept at making data-driven decisions and managing complex safety challenges.

4. What challenges can I expect in this role?

You may encounter challenges such as navigating evolving global regulatory landscapes, integrating safety data from diverse sources, and responding swiftly to emerging safety signals. Ensuring inspection readiness and maintaining compliance amid rapid product development will also be key priorities.

5. How does the Director of Drug Safety impact the company’s success?

Your leadership will be vital in protecting patient health, ensuring regulatory compliance, and supporting the company’s reputation for safety and quality. Effective drug safety management will facilitate successful product launches, regulatory approvals, and sustained market presence.

6. What is the company’s culture and work environment like?

The company promotes a collaborative and innovation-focused culture that values integrity, transparency, and continuous improvement. You will work alongside passionate professionals dedicated to advancing healthcare and improving patient outcomes.

What Remuneration Can You Expect from This Job?

As the Director of Drug Safety in a leading Big Pharma company based in San Francisco, CA, you can anticipate a highly competitive compensation package crafted to attract experienced leaders in pharmaceutical safety and compliance. The remuneration for this role typically includes:

1. Base Salary
The base salary for a Director of Drug Safety in the pharmaceutical industry varies depending on company size, product portfolio, and experience level. Generally, the annual base salary ranges from $180,000 to $300,000, with larger multinational corporations offering salaries toward the higher end.

2. Performance-Based Bonuses
In addition to the base salary, you may receive annual performance bonuses tied to key metrics such as regulatory compliance, safety milestone achievements, team performance, and contribution to product safety strategy. These bonuses can range from 15% to 40% of the base salary.

3. Equity & Stock Options
Many pharmaceutical companies provide equity incentives, such as stock options or restricted stock units (RSUs), to align your interests with long-term company success. Equity awards can significantly enhance your total compensation, especially in publicly traded firms.

4. Long-Term Incentive Plans (LTIPs)
You may be eligible for LTIPs that reward sustained excellence and leadership in drug safety, supporting both your financial growth and company stability over multiple years.

5. Executive Benefits & Perks
The role typically includes a comprehensive benefits package, such as:

Health, dental, and vision insurance
Retirement savings plans with company matching
Wellness programs and employee assistance
Professional development opportunities
Flexible work arrangements and travel allowances

6. Signing Bonuses & Relocation Assistance
For top candidates, companies often offer signing bonuses and relocation support to facilitate a smooth transition to the San Francisco area. These incentives can range from $20,000 to $100,000, depending on the level of expertise and company policy.

Total Compensation Potential

When combining base salary, bonuses, equity, and other incentives, total annual compensation for the Director of Drug Safety role can range from $250,000 to $450,000 or more, reflecting the critical nature of the position in safeguarding patient health and regulatory compliance.

How to Apply

If you are an experienced and visionary leader in drug safety and pharmacovigilance, we encourage you to apply for the Director of Drug Safety role at a leading Big Pharma company in San Francisco, CA. This is an exceptional opportunity to oversee critical drug safety operations, ensure regulatory compliance, and protect patient health on a global scale.

To apply, please submit your resume along with a cover letter highlighting your expertise in drug safety leadership, regulatory compliance, risk management, and team development. Emphasize your experience with safety signal detection, pharmacovigilance systems, and collaboration with cross-functional teams to drive safety excellence.

This role offers a high-impact career path where you will play a pivotal role in shaping drug safety strategies, fostering a culture of safety, and ensuring the company’s commitment to patient welfare and regulatory standards. Apply today to advance your career as Director of Drug Safety in the pharmaceutical industry’s dynamic environment.

For more information or to explore similar opportunities, please visit our Big Pharma Recruiting Experts Page.

Job Category: Big Pharma

Job Type: Full Time

Job Location: San Francisco

Director Drug Safety Big Pharma – San Francisco, CA