Senior Manager of Pharmacovigilance
Location
United States
Posted
2 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Senior Manager of Pharmacovigilance
ICON plc
Role Description The Senior Manager of Pharmacovigilance will be responsible for the execution of global pharmacovigilance activities supporting late-stage clinical development and preparation for first commercial launch of small-molecule oncology products in lung and prostate cancer. This role will ensure compliance with global safety regulations and will work closely with cross-functional partners to ensure individual case safety report (ICSR) processing, Health Authority submissions, and post-marketing safety readiness. This is a hands-on role well suited for a biotech environment requiring both operational excellence and cross-functional collaboration. Job Description - Global Drug Safety & Pharmacovigilance Operations - Manage end-to-end pharmacovigilance activities for clinical trials and post-approval oncology products. - In partnership with Clinical Research Organizations (CROs), oversee intake, assessment, processing, medical review, and reporting of ICSRs from clinical trials, adhering to established processes and timelines. - Ensure timely submission of expedited and periodic safety reports to Regulatory Authorities, IRBs/ECs, clinical investigators, and business partners. - Support preparation and submission of DSURs, periodic safety reports/listings, and updates to Investigator Brochures (IBs). - Develop, maintain and execute Safety Management Plans for clinical studies. - Clinical Development & Regulatory Affairs Support - Contribute to safety sections of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and IND/NDA/MAA/CTAs (as applicable). - Review clinical trial safety data and assist with data cleaning for ongoing studies. - Participate in periodic safety reviews, signal detection and risk evaluation activities. - Maintain Reference Safety Information for the client's products and co-administered IMPs. - Support launch readiness activities including development of post-marketing pharmacovigilance processes, development and maintenance of Risk Management Plans (RMPs) and REMS (as applicable). - Assist with preparation for regulatory inspections and audits. - Cross-Functional Collaboration - Participate in internal Safety Management Teams and governance meetings. - Partner with Clinical, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams. - Support safety training for internal stakeholders and investigators. - Vendor & Compliance Oversight - Support oversight of pharmacovigilance vendors and service providers. - Ensure Safety Data Exchange Agreements (SDEAs) are implemented and maintained. - Assist in development and maintenance of SOPs and training materials. Qualifications - Bachelor’s degree in life sciences, pharmacy, nursing, or related discipline with demonstrated knowledge of medical terminology. - 12 years’ pharmacovigilance experience with Bachelor's degree -or- 8 years’ experience and Master's degree -or- 5 years’ experience and PhD - including clinical trial and/or post-marketing experience. - Experience with small-molecule oncology products. - Working knowledge of global pharmacovigilance regulations, including FDA, EMA, Health Canada, and Asian Health Authorities (e.g., Japan PMDA, South Korea MFDS). - Experience using validated safety databases (e.g., Argus, ARISg) and clinical trial databases. Preferred Qualifications - Oncology experience in lung and/or prostate cancer. - Experience in biotech/small pharmaceutical company or CRO environments. - Experience supporting NDA/MAA submissions and commercial launch. - Familiarity with REMS, RMPs, and post-marketing commitments. Skills and Attributes - Strong strategic thinking combined with a hands-on, execution-focused mindset. - Proven ability to collaborate and lead in a cross-functional, matrixed organization. - Excellent written and verbal communication skills, with the ability to convey complex data clearly. - Highly organized, adaptable, and comfortable working in a fast-paced, evolving environment. - Mission-driven, patient-focused, and committed to scientific integrity. Requirements - To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status. - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location.
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Renewals Senior Manager
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About Us Fieldguide is the AI-native platform for audit and advisory — the place where practitioners and agents work together to deliver higher quality work, faster, and with better client outcomes. Over 50 of the top 100 accounting and consulting firms trust Fieldguide to accelerate growth, improve quality, and transform the way audit and advisory work gets done. We're rooted in San Francisco, CA, but built as a remote-friendly, global company. We're backed by top investors including Growth Equity at Goldman Sachs Alternatives, Bessemer Venture Partners, 8VC, Floodgate, and Y Combinator. We value diversity — in backgrounds and in experiences. We need people from all backgrounds and walks of life to help build the future of audit and advisory. Fieldguide's team is inclusive, driven, humble, and supportive. We are deliberate and self-reflective about the kind of team and culture we are building, seeking teammates who are not only strong in their own aptitudes but care deeply about supporting each other's growth. If you share our values and enthusiasm for building a great culture and product, you will find a home at Fieldguide. About the Role Fieldguide is an AI-native platform built for audit, advisory, and assurance workflows. Our customers are sophisticated accounting and advisory firms that operate in highly regulated environments, maintain long-term vendor relationships, and respond to renewal motions that are consultative and value-based. We're growing fast, and retention and expansion are core to the business. Reporting to the VP of Sales, this is a build-and-run role. There's no team to inherit and no playbook to follow. You'll own the full renewal lifecycle across our customer base — from first conversation through contract execution — while building the processes, systems, and frameworks that scale with the business. As the function grows, you'll have the opportunity to hire and develop a team of Renewals Specialists. The right person for this role has done the IC work, is ready to own outcomes rather than advise on them, and has the commercial instincts and credibility to build a renewals motion at a fast-moving Series C company. What You'll Do Own the Renewal Motion - Manage the full renewal lifecycle for all accounts: outreach, risk triage, negotiation, and close - Maintain a rolling 90-120 day renewal forecast; report weekly on pipeline health, risk, and expected outcomes - Develop a data-driven renewal strategy for each account before entering any negotiation, factoring in customer health, usage trends, stakeholder dynamics, and risk - Lead commercial negotiations directly with customers, including executive-level conversations on multi-year and at-risk accounts - Drive price increases, multi-year structures, and expansion identification at contract renewal - Work closely with CSEs to identify churn signals early and build mitigation strategies - Maintain clean renewal data and pipeline hygiene in HubSpot Build the Renewals Function - Build the renewals playbook from scratch: outreach cadences, escalation frameworks, negotiation guidelines, and segment-specific engagement models - Own the KPI framework for renewals — anchor it in leading indicators like MAU/WAU and consumption pacing, not just trailing metrics like GRR and NRR; establish the reporting cadence with Finance and CS leadership — this role shapes what the function measures - Design tiered engagement models across Strategic, Enterprise, Mid-Market, and SMB customer segments - Partner with Finance on Available-to-Renew (ATR) tracking and integration into the ARR forecast - Implement AI-assisted workflows for health scoring, churn risk flagging, and renewal automation where appropriate - Be the go-to resource on renewals best practices internally, setting the standard for how Fieldguide approaches retention and expansion Drive Cross-Functional Alignment - Represent renewal risk in deal reviews, QBRs, and exec-level revenue conversations - Partner with CSMs on health scores and churn signals — as part of the same team, this is a tight loop, not a handoff - Work with Product to access and interpret usage data (MAU/WAU, entitlement pacing, feature adoption) and translate it into renewal risk signals and customer conversations - Work with Finance on cohort analysis, GRR/NRR attribution, and retention economics - Coordinate with Legal and Deal Desk on non-standard contract structures - Feed customer signals back to Product and GTM leadership: usage trends, objections, competitive pressure, value realization About You - You have 7+ years in SaaS renewals, customer success, or commercial account management, with a track record of personally owning and hitting GRR/NRR targets - You've built a renewals function or motion from scratch — you wrote your own playbooks; you didn't inherit them - You're a strong commercial negotiator, comfortable leading high-stakes conversations at the CFO or executive level - You're analytically fluent: you can build a renewal forecast, segment a book of business by risk, and present cohort-level retention performance to leadership - You're CRM-proficient; HubSpot is strongly preferred, Salesforce is acceptable - You're an effective cross-functional operator who builds credibility through rigor and follow-through, able to influence Sales, Finance, and Legal without direct authority - You're ready to manage a small team; prior people management experience is preferred but not required for the right candidate - You're comfortable in a fast-moving environment where the playbook is still being written Bonus Points - Background in audit, accounting, or professional services, or experience selling to those firms — Fieldguide's customers are sophisticated practitioners, and knowing how they buy, budget, and evaluate software matters - Experience in AI-native SaaS or with AI workflow tools (health scoring, churn prediction, automated renewal triggers) - Experience scaling a renewals function through a Series B or C inflection point More about Fieldguide Fieldguide is a values-based company. 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