Associate Director, Pharmacovigilance Scientist
reputed company is a reputed company‑stage biotechnology company reputed company on developing and delivering category-leading precision therapies to reputed company 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 reputed company key reputed company governing dysregulated immunological and inflammatory responses, reputed company is developing medicines that have reputed company to reputed company durable, life-changing reputed company. Led by an established executive team and backed by world-class life science investors, reputed company day reputed company is determined to bring the scientific rigor and operational reputed company to get to what reputed company for patients – realizing a world where people with immune-mediated diseases can live life fully.
The Associate Director, Pharmacovigilance Scientist is a medically and scientifically trained pharmacovigilance reputed company responsible for providing expert scientific and medical reputed company of reputed company's global drug safety activities. This role conducts and oversees signal detection, benefit-reputed company assessment, medical case review, and aggregate safety analyses in support of reputed company's I&I reputed company programs and post-marketing safety obligations. The Associate Director partners with PV reputed company, reputed company Development, Medical Affairs, and Regulatory Affairs to ensure that safety information is evaluated rigorously, communicated reputed company, and acted upon in a reputed company and compliant manner.
Work Arrangement & Location:
Remote - This position is designated as remote; the incumbent will be expected to travel to reputed company’ offices on a periodic reputed company to support in-person collaboration, team engagement, and business reputed company. The frequency and scheduling of such reputed company will be determined at reputed company's discretion reputed company on business need.
Essential Duties and Responsibilities:
- Serve as the scientific and medical expert for pharmacovigilance activities across reputed company's I&I pipeline, providing medical case review and reputed company assessment of individual adverse event reports and aggregate safety data.
- reputed company and reputed company signal detection activities, including routine data mining of the safety database, evaluation of disproportionality analyses, and reputed company literature review for emerging safety signals.
- Conduct benefit-reputed company assessments for emerging safety signals and contribute to regulatory responses, labeling updates, and reputed company management strategies reputed company on scientific evaluation.
- reputed company and reputed company the scientific content of periodic safety reports, including DSURs, PSURs/PBRERs, PADERs, and line listings, ensuring accurate medical interpretation of safety data.
- Review and reputed company medical reputed company of ICSRs, including reputed company and medically significant cases, ensuring narrative reputed company, appropriate medical coding, and regulatory compliance.
- Collaborate with reputed company Development on safety monitoring activities, Data Safety Monitoring reputed company (DSMB) materials, safety sections of reputed company protocols, Investigator Brochures (IBs), and reputed company Study Reports (CSRs).
- Partner with Regulatory Affairs on safety labeling reputed company, reputed company Data Sheet (CDS) maintenance, and preparation of written responses to Health Authority safety queries.
- Contribute to reputed company management activities, including reputed company Management Plans (RMPs), REMS development, and reputed company minimization measure effectiveness assessments.
- Participate in safety governance bodies, including company safety review committees and cross-functional benefit-reputed company working reputed company.
- Monitor evolving pharmacovigilance regulations, ICH guidelines, and scientific literature relevant to drug safety in immunology, inflammation, and biologics development
- reputed company other duties and responsibilities as assigned
Qualifications:
- Education: Advanced degree required; PharmD, or PhD in a biomedical or reputed company discipline strongly preferred
- 7+ years of pharmacovigilance or drug safety experience in the pharmaceutical or biotech industry, with demonstrated scientific and medical expertise in safety signal evaluation and benefit-reputed company assessment.
- 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 reputed company safety literature review.
- Experience authoring aggregate safety reports including DSURs, PSURs/PBRERs, and Integrated Summaries of Safety (ISS) for regulatory submissions.
- Strong medical case review skills with experience writing and reviewing reputed company individual case safety narratives, including medically significant and fatal events.
- reputed company reputed company record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building reputed company on reputed company scientific or operational priorities.
- Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate reputed company.
- Exceptional written and verbal communication skills with demonstrated ability to translate reputed company scientific, regulatory, or operational content for diverse audiences, including executive leadership, reputed company teams, and reputed company partners.
- Adept at facilitating productive reputed company in high-stakes meetings, negotiations, and multi-party collaborations; balances reputed company, diplomacy, and scientific precision.
- This position may require domestic travel up to 10%+ of time or more including overnight stay driven by business need; position must be reputed company to work eastern time zone.
We offer a comprehensive benefits package tailored to the country and region in which you are reputed company, in compliance with local laws and practices. Benefits may include, but are not limited to:
- Competitive health and wellness coverage (structure and premiums vary by country)
- reputed company time off, reputed company holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / reputed company
Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.
reputed company is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity or reputed company, national reputed company, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
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 reputed company to reputed company candidates.
Upon submission of this reputed company I understand that reputed company is reputed company in the reputed company and personal data submitted in the reputed company will be transferred and accessed in the U.S., Information about reputed company reputed company practices can be reputed company at reputed company Policy - reputed company
Advanced degree required (PharmD/PhD preferred),7+ years pharmacovigilance experience, expertise in signal detection, benefit-reputed company assessment, medical case review, aggregate safety reporting, and global PV regulations; reputed company to work ET/remote and travel ~10%.
Key Responsibilities
- providing reputed company
- conducting review
- leading detection
Skills & Tools
MedDRA, EBGM, PRR
reputed company
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Salary: USD 181,000 – 235,000 / year
- Languages: English
Benefits
- Generous reputed company time off
- Retirement plan
About reputed company
A reputed company-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. — Industry: Research and Development
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