Beeline Medicines

Associate Director, Pharmacovigilance Scientist

United States · Director

Sponsorship not specified$204k-$213kDetected 20 days ago

ICD-10FDA RegulatoryPharmacovigilanceLeadershipCommunicationCollaborationRegulatory Affairs

About the role

The Associate Director, Pharmacovigilance Scientist is a medically and scientifically trained pharmacovigilance professional responsible for providing expert scientific and medical oversight of the company's global drug safety activities.
Remote - This position is designated as remote
The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

Lead and oversee signal detection activities, including routine data mining of the safety database, evaluation of disproportionality analyses, and systematic literature review for emerging safety signals.
Collaborate with Clinical Development on safety monitoring activities, Data Safety Monitoring Board (DSMB) materials, safety sections of clinical protocols, Investigator Brochures (IBs), and Clinical Study Reports (CSRs).
Perform other duties and responsibilities as assigned

Deep knowledge of global PV regulatory frameworks, including FDA 21 CFR, EU GVP Modules, ICH E2A-E2F guidelines, and MedDRA coding conventions.
Demonstrated experience leading or contributing to signal detection programs, including use of pharmacovigilance databases, EBGM/PRR analyses, and systematic safety literature review.
Experience authoring aggregate safety reports including DSURs, PSURs/PBRERs, and Integrated Summaries of Safety (ISS) for regulatory submissions.
Experience navigating organizational ambiguity and change
capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
Adept at facilitating productive dialogue in high-stakes meetings, negotiations, and multi-party collaborations
balances clarity, diplomacy, and scientific precision.
This position may require domestic travel up to 10%+ of time or more including overnight stay driven by business need

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired.
Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law.
A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.
$203,837 - $212,850 USD
Equal Employment Opportunity:
We celebrate diversity and are committed to creating an inclusive environment for all employees.

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices.
Competitive health and wellness coverage (structure and premiums vary by country)
Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
Specific benefit details applicable to your country or region will be provided during the offer process.
Benefits may include, but are not limited to:
Flexible work arrangements / hybrid schedule
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms.

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.
With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.
Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.
Serve as the scientific and medical expert for pharmacovigilance activities across the company's I&I pipeline, providing medical case review and clinical assessment of individual adverse event reports and aggregate safety data.
Participate in safety governance bodies, including company safety review committees and cross-functional benefit-risk working groups.

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation.
We are committed to providing equal access to all candidates.
Beeline Medicines is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

This listing is sourced directly from Beeline Medicines's careers page and normalized into a canonical job model.