New · posted Nov 11
Alnylam Pharmaceuticals · Biotechnology
Director, Pharmacovigilance & Safety Technology
- Cambridge, MA
- Hybrid
- Full-time
- Director
The role
Alnylam is the world’s leading RNA interference (RNAi) company, dedicated to transforming patients’ lives through innovative medicines. As the global development and commercial portfolio expands, Safety & Risk Management requires scalable, compliant, and data-driven technology capabilities that support high-quality pharmacovigilance across investigational and marketed products.
The Director, Pharmacovigilance & Safety Technology shapes and executes the technology strategy for Safety & Risk Management and related safety functions. As the primary business technology leader for Safety, this role ensures that platforms, data, integrations, analytics, reporting, and digital workflows enable compliant, efficient, inspection-ready, and insight-driven operations across the product lifecycle.
Reporting to the Executive Director, Commercial & Development Technologies, this role directly manages two experienced technology professionals at the Manager and Senior Manager levels. The role translates Safety priorities into a practical roadmap and leads execution and additional work through its team, product owners, application teams, managed service providers, vendors, and cross-functional partners.
Success in this role requires strong pharmacovigilance-domain business acumen, technical fluency across regulated safety platforms, and the ability to translate safety priorities into a practical technology roadmap. The leader will be expected to connect strategy to execution—partnering with Safety leadership, enterprise Technology, Data, Quality, Security, Compliance, Validation, and vendor teams to deliver scalable, compliant, secure, and user-centered solutions. Rather than serving as a single-system product owner or duplicating Safety Operations responsibilities, this role provides functional technology leadership across the broader PV and safety capability landscape.
This role is Hybrid, based in Cambridge, MA with 2-3 days onsite.
PV Systems, Data & Architecture Leadership
- Provide technology leadership in the design and evolution of PV systems, safety data models, integrations, reporting architecture, analytics capabilities, dashboards, workflow automation, and platform interoperability across the safety ecosystem.
- Partner with Data and Analytics teams to enable cross-system reporting, traceability, compliance metrics, quality performance indicators, signal detection, and safety insights while maintaining clear data ownership, security, privacy, and compliance boundaries.
- Enable and govern technology capabilities used by Safety teams for case intake, triage, medical review, narrative support, expedited reporting, aggregate reporting, signal management, risk management, literature surveillance, inspection readiness, and global submission obligations.
- Evaluate and govern emerging digital, automation, analytics, and AI-enabled capabilities for PV, balancing business value with validation, compliance, responsible-use, and adoption requirements.
- Translate complex technical, safety, regulatory, validation, and compliance considerations into clear guidance, decisions, and tradeoffs for functional leadership and operational teams.
Cross‑Functional & Lifecycle Collaboration
- Collaborate closely with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, Commercial, Patient Services, Data, and enterprise Technology teams to ensure safety systems integrate effectively across the product lifecycle and support both investigational and post-marketing obligations.
- Enable global PV operations through technology solutions that scale across regions, affiliates, partners, vendors, products, studies, programs, reporting destinations, and evolving regulatory expectations.
- Partner with Quality, Security, Privacy, Records Management, Compliance, Validation, and Safety leadership to ensure technology solutions meet internal procedures, global regulatory expectations, audit requirements, and inspection readiness standards.
Vendor, Platform & Operational Leadership
- Collaborate with external safety system vendors, product owners, application support teams, managed service providers, and enterprise technology partners to deliver system implementations, integrations, upgrades, enhancements, migrations, reporting capabilities, and technology-enabled operational improvements for PV and Safety.
- Guide delivery and support partners with sufficient functional and technical depth to challenge solution designs, assess architecture and data tradeoffs, and ensure delivered capabilities meet compliance, scalability, usability, integration, and operational support standards.
- Proactively identify system, data, reporting, integration, workflow, and technical gaps in safety systems and recommend pragmatic technology improvements that reduce operational burden and strengthen compliance.
- Apply root cause analysis to resolve complex technology issues affecting case processing, regulatory reporting, safety data quality, integrations, system performance, or operational delivery.
- Act as the technology escalation point for critical system issues impacting PV, Safety Operations, regulatory reporting, signal detection, inspection readiness, or safety business continuity.
What you need
- Degree in Information Technology, Computer Science, Data Science, Life Sciences, Pharmacy, or related field, with significant experience in regulated life sciences environments.
- 12+ years of experience in life sciences technology, pharmacovigilance systems, safety technology, drug safety operations technology, safety data management platforms, PV systems modernization, or related regulated technology roles.
- Deep understanding of PV processes sufficient to lead technology design, governance, and delivery across safety databases such as Argus or comparable commercial safety platforms, case intake and processing workflows, regulatory reporting, signal detection tools, aggregate reporting, risk management, and safety analytics.
- Working knowledge of global pharmacovigilance regulatory requirements and industry standards, including FDA, EMA, ICH guidelines, 21 CFR Part 11, GxP validation, data integrity, MedDRA structure, and inspection readiness expectations.
- Significant experience shaping technology strategy and capability roadmaps in GxP-regulated environments, ideally across platforms, processes, data, integrations, reporting, and analytics workflows.
- Demonstrated ability to operate at both strategic and technical depth, including evaluating architecture options, validation approaches, data integration strategies, reporting tools, vendor solutions, and operational support models.
- Experience with PV technologies and adjacent tools such as safety gateways, reporting platforms, dashboards, Oracle or SQL-based data environments, analytics platforms, signal detection tools such as Empirica or Spotfire, and enterprise integration services.
- Strong understanding of AI, automation, advanced analytics, and responsible AI governance considerations in regulated PV environments, including how to assess use cases, validation needs, compliance risks, and adoption requirements.
- Proven business analysis skills with strong analytical, problem-solving, prioritization, project management, and stakeholder management abilities.
- Strong team player with the ability to influence across Safety, Technology, Quality, Compliance, Data, vendors, and senior business stakeholders.
- Excellent oral and written communication skills, with the ability to translate technical, regulatory, and compliance topics into clear business decisions and executive-ready recommendations.
- Demonstrated people leadership experience, including direct responsibility for coaching, developing, and managing experienced technology professionals and building high-performing internal and partner delivery teams.
What you'll do
- Serve as the primary business technology functional leader and strategic partner for Safety & Risk Management, Safety Operations, Pharmacovigilance, Risk Management, and related safety functions, building trusted relationships with functional leadership to understand objectives, priorities, pain points, and technology needs.
- Define and maintain the safety technology roadmap, translating Safety business priorities and requirements into prioritized platform investments, process-enabling technology capabilities, data enablement, automation, and AI-enabled solution opportunities.
- Lead the technology direction, prioritization, and continuous improvement of platforms and workflows supporting end-to-end pharmacovigilance, including case management, regulatory reporting, signal and risk management, aggregate reporting, safety analytics, and related integrations.
- Own the technology partnership model for supported safety functions, including demand shaping, prioritization, business case development, solution alignment, delivery oversight, adoption planning, operational readiness, and value realization.
- Establish clear accountability across the Safety technology operating model: Safety owns business outcomes, processes, and requirements, while Technology owns solution strategy, platform oversight, delivery, governance, and operational reliability.
- Establish and enforce technology governance, standards, and best practices, including data privacy, security, validation, records management, inspection readiness, 21 CFR Part 11, data integrity, and compliance with global PV regulatory requirements.
- Partner with product owners, application teams, service providers, and vendors to align platform priorities, releases, validation, support models, and service performance with Safety business needs.
- Lead, coach, and develop a team of technology professionals, establishing clear accountabilities, priorities, performance expectations, and development plans while building an effective operating model across internal teams, vendors, and delivery partners.
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Alnylam
We are the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them. Founded based on Nobel Prize-winning science, our work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of RNAi therapeutics possible. Guided by core values like fierce innovation, purposeful urgency, and passion for excellence, our open and inclusive culture drives everything we do. We are proud to be globally recognized as a top employer, where people feel valued and breakthrough thinking flourishes.
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Director roles in Massachusetts25 roles publishing pay
Director roles in the US83 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Massachusetts (middle half) | $210,000 | $230,000 | $312,500 |
| All US (middle half) | $223,750 | $262,500 | $279,250 |
Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 160 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership20
- GMP and compliance16
- Validation and qualification9
- Data and digital systems7
- Quality systems and risk6
- Investigations and CAPA3
- Documentation and SOPs2
- Lab testing and methods1
- Regulatory submissions1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Safety & Pharmacovigilance work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical historyNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA good pharmacovigilance practices(official source, opens in a new tab)Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
- FDAFDA FAERS(official source, opens in a new tab)The FDA Adverse Event Reporting System for drugs and biologics
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EMAEU Good Pharmacovigilance Practices (GVP)(official source, opens in a new tab)EMA's modules for pharmacovigilance systems, signals and periodic reports
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Alnylam on Regulatory Jobs
- 15
- Open roles
- 15
- Distinct roles
- 4
- Locations
By discipline
- Clinical9 60%
- Regulatory3 20%
- Quality3 20%
By level
- Director9 60%
- Manager2 13%
- Associate & Specialist2 13%
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Director, Pharmacovigilance & Safety Technology at Alnylam
Open until filled.