Pharmacovigilance CEO

Hi,

This is Sandeep from Radient.AI and please find the job description below which suits your profile and let us know your interest for this position

Job Title: Pharmacovigilance CEO

Client:

Implementation:

Duration: Fulltime

Experience level: 15+ Experience 

Location: USA (Remote)

Job Title: President & Chief Executive Officer (CEO)

(Alternate title options: Chief Growth Officer (CGO) or President, depending on governance and board preference)

Location: Hybrid (USA)

Reports To: Board of Directors / Partners

Direct Reports: Heads of Pharmacovigilance, Clinical Operations & Documentation, Regulatory Affairs, Business Development, Finance, HR, Technology, and Quality/Compliance

Company Overview

4C Pharma Solutions is a life sciences services company delivering pharmacovigilance, clinical data/documentation, and regulatory solutions to pharmaceutical and biotech clients. We combine deep domain expertise with technology-led delivery—spanning safety case processing, literature surveillance, aggregate reporting, MedDRA coding/decoding, oncology documentation workflows, and end‑to‑end regulatory support. Our next phase of growth focuses on global scale-up, service innovation, and operational excellence.

Role Purpose

The President & CEO will lead 4C Pharma Solutions through its next growth horizon—owning the strategy, P&L, client expansion, operational scale, and talent agenda. This leader will translate vision into executable roadmaps, strengthen delivery excellence in PV/clinical documentation and regulatory services, and build repeatable growth engines via partnerships, digital platforms, and differentiated offerings.

Key Responsibilities

1) Strategic Growth & Market Leadership

Define and drive a 3–5 year strategic plan with clear market, service line, and geographic priorities.

Identify and launch new service offerings (e.g., signal detection, benefit–risk, RWE analytics, regulatory publishing) and technology-enabled products (e.g., PV workflow automation; MedDRA API expansion).

Build strategic partnerships with pharma/biotech sponsors, CROs, technology vendors, and data providers to accelerate scale.

2) Commercial Excellence & Client Expansion

Own sales & revenue growth targets with a focus on EU markets and mid-to-large sponsor accounts.

Oversee solutioning & proposals, pricing strategy, and enterprise contract negotiations.

Establish a key account program with executive sponsorship, QBRs, and measurable value creation for top 10 accounts.

3) Operational Excellence & Delivery Quality

Ensure compliant, efficient, and scalable delivery across PV case processing, literature surveillance, aggregate reporting, and clinical documentation (incl. oncology).

Standardize SOPs, SLAs/OLAs, QA frameworks, and right-first-time metrics; reinforce inspection-readiness.

Deploy digital/automation (e.g., workflow engines, AI-assisted coding/decoding, data validation) to improve TAT, quality, and margin.

4) Regulatory, Quality & Risk Management

Uphold global regulatory compliance and audit readiness (e.g., GVP, ICH, FDA, EMA).

Chair Quality & Compliance reviews, ensuring remediation plans and CAPAs are executed.

Implement enterprise risk management—operational, financial, legal, data privacy, and cybersecurity.

5) Finance, P&L Ownership & Capital Stewardship

Own P&L—revenue, gross margin, EBITDA, cash flow.

Optimize pricing, utilization, and delivery mix; implement cost discipline and ROI-based investments.

Prepare board packs, financial forecasts, and capital allocation proposals.

6) Leadership, Culture & Organization Building

Build a high-performing leadership team; clarify roles, goals, and accountability.

Strengthen talent pipelines for PV, regulatory, and clinical documentation (including EPIC/oncology experience).

Foster a culture of client-centricity, quality, innovation, and ownership.

7) Technology & Data Strategy

Partner with Technology to advance PV platforms, MedDRA coding/decoding APIs, documentation workflows, and analytics/reporting.

Champion data integrity, automation, and secure-by-design architectures.

Candidate Profile

Experience

15+ years in pharma services/CRO/life sciences consulting, with 5+ years in a senior P&L leadership role.

Demonstrated scale-up experience; led multi-site operations and global client portfolios.

Proven track record driving double‑digit YoY growth, large account management, and complex solution delivery.

Exposure to pharmacovigilance operations, clinical documentation (incl. oncology), regulatory publishing/strategy, and quality/compliance.

Education

Advanced degree in Life Sciences/Pharmacy/Medicine or MBA (preferred).

Training/certifications in GVP/ICH, MedDRA, quality systems, or regulatory frameworks are a plus.

Competencies

Strategic thinking and execution discipline.

Commercial acumen and enterprise negotiation.

Operational rigor; KPI-driven management.

Leadership presence; talent development; cross-functional collaboration.

Customer-centric mindset; strong communication and stakeholder management.

Tech fluency with PV/clinical documentation platforms and API-led architectures.

Key Performance Indicators (KPIs)

Revenue Growth: ≥ 25–35% YoY (target to be finalized with Board).

Gross Margin / EBITDA: Improved by 300–500 bps through optimization and automation.

Client Metrics:

Top 10 accounts: NPS ≥ 60, renewal rate ≥ 90%.

New logo acquisitions: 5–8 per year in target markets.

Operational Excellence:

Case processing accuracy ≥ 99%, TAT within SLA ≥ 95%.

Zero critical findings in audits/inspections; timely CAPA closure.

Talent & Culture:

Leadership bench strength; attrition ≤ industry benchmark.

Defined competency maps, learning hours per FTE, and internal mobility.

Innovation:

Launch 2–3 new offerings/tech accelerators annually (e.g., PV automation modules, oncology documentation accelerators, MedDRA API enhancements).

Thanks & Regards,

Sandeep Siliveru,

Lead Recruiter

Radient.AI

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