Executive Director, Pharmacovigilance (PV), Remote

SAB•Sioux Falls, SD

1d•$325,000 - $360,000•Remote

About The Position

The Executive Director, Pharmacovigilance (PV) is a senior individual contributor and team leader responsible for end-to-end pharmacovigilance activities supporting late-phase clinical development and regulatory submissions for the company’s biologic pipeline. The role leads global safety surveillance, aggregate safety reporting, and preparation of integrated safety documents for BLA and MAA filings in a fast-paced, resource-lean biotech environment. The position oversees Phase 3 and registrational biologics PV operations, global signal detection and assessment, safety data workflows, safety reporting infrastructure, vendor relationships, safety labeling, and risk-management activities. It also contributes PV expertise to regulatory submissions and health-authority interactions, including responses to safety-related questions. The role partners across clinical development, regulatory affairs, medical affairs, clinical pharmacology, biostatistics, and commercial teams, and represents PV in development and program team meetings. The position currently has no supervisory responsibilities; these may be added in the future. The work is performed in a home-office environment and includes an estimated 10–20% domestic and international business travel. The expected US salary range is $325,000–$360,000. The role is generally eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the company’s benefit plans.

Requirements

MD degree from an ECFMG-accredited institution.
Current or former physician medical license issued in a country where the SAB-142 Clinical Development Program is being executed: USA, UK, EU, New Zealand, or Australia.
12 or more years of progressive pharmaceutical or biotech industry pharmacovigilance experience, including at least 5 years in a senior role with direct accountability for late-phase global biologics PV programs.
Hands-on authorship of Integrated Safety Summaries submitted in at least one BLA or MAA.
Extensive experience authoring CSR safety sections, DSURs, and PSURs/PBRERs for biologic compounds in global development.
Deep knowledge of ICH guidelines E2A–E2E, E6, E8, and M4E; FDA/CDER and EMA GVP requirements; and regional PV regulations, including EU, US, Japan, and other ICH regions.
Extensive experience with signal detection methodologies, benefit-risk assessment frameworks, and safety narrative writing.
Experience managing CRO/vendor PV relationships and overseeing safety databases such as Argus, ARISg, or equivalent.
Exceptional scientific and medical writing skills, including the ability to synthesize complex safety data into clear regulatory documents under tight timelines.
Strong analytical and critical-thinking skills, including the ability to independently evaluate complex safety signals and formulate evidence-based recommendations.
Ability to engage and challenge clinical, statistical, and regulatory colleagues at a peer level with scientific credibility.
Excellent project-management skills and ability to manage competing priorities without sacrificing quality.
Demonstrated leadership and cross-functional collaboration.
Regularly walk, stand, and sit; regularly lift and/or move up to 10 pounds.
Travel domestically and internationally for business, estimated at 10–20%.

Nice To Haves

Experience in small biotech or start-up environments and comfort working with limited infrastructure and high personal accountability.
Experience with BLA or MAA approval for a biologic; post-approval pharmacovigilance experience is a plus.
Familiarity with rare disease, orphan drug, or first-in-class biologic programs.
Experience presenting to Health Authorities such as the FDA and EMA, and participating in Advisory Committee proceedings.
Familiarity with REMS design and implementation or EU RMP preparation.
Knowledge of pharmacoepidemiology methodologies and real-world evidence applications in safety assessment.
Experience with multiple BLA or MAA submissions.

Responsibilities

Lead and execute pharmacovigilance activities for Phase 3 and registrational biologics programs in compliance with applicable ICH guidelines and regional requirements.
Oversee global signal detection, evaluation, and management, including MedDRA coding review and benefit-risk assessment updates.
Manage safety data receipt, processing, and reporting workflows in collaboration with CROs, data management teams, and clinical operations.
Serve as the PV subject-matter expert and primary contact for cross-functional clinical teams, regulatory affairs, and medical affairs.
Maintain the global safety database and adverse-event reporting infrastructure, including vendor oversight.
Author or oversee Integrated Safety Summaries and contribute to Integrated Summaries of Efficacy for BLA and MAA submissions.
Oversee safety labeling strategy and compliance with global regulatory requirements, including requirements for boxed warnings, REMS, restricted access programs, and other post-marketing risk mitigation obligations.
Lead development of Clinical Study Report safety sections for Phase 2 and Phase 3 studies, including narratives, adverse-event tabulations, and laboratory data analyses.
Prepare and manage PSURs, PBRERs, and DSURs according to global schedules.
Prepare Risk Management Plans and Risk Evaluation and Mitigation Strategies, including strategy development and execution.
Respond to health-authority safety questions and information requests during regulatory reviews.
Design and implement pharmacovigilance surveillance programs, benefit-risk monitoring frameworks, and clinical-trial safety monitoring plans.
Conduct and document signal detection; prepare signal assessment reports and escalate findings to the Safety Monitoring Committee and/or DSMB as appropriate.
Work with clinical pharmacology and biostatistics teams to interpret safety trends across populations and study designs.
Support post-marketing commitments and Phase 4 safety studies, including protocol development and safety monitoring plans.
Partner with Clinical and Regulatory Affairs on global filing strategy and PV regulatory timelines; represent PV in health-authority meetings and advisory committee preparations.
Collaborate with Medical Affairs and Commercial teams on labeling updates, healthcare professional communications, and post-approval safety activities.
Establish and maintain SOPs, work instructions, and quality standards; mentor and manage a small PV team or oversee contract resources as the company scales.
Evaluate, select, and manage pharmacovigilance CRO and vendor partnerships, conduct oversight audits, and ensure GVP compliance.
Represent PV on the Clinical Development Team and participate in Program Team leadership meetings.