[Hiring] Associate Director, Pharmacovigilance Scientist @reputed company

Role reputed company 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-risk assessment, medical case review, and aggregate safety analyses in support of reputed company's I&I clinical programs and post-marketing safety obligations. The Associate Director partners with PV Operations, Clinical 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: • 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 operations. • The frequency and scheduling of such reputed company will be determined at reputed company's discretion based 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 clinical 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 systematic literature review for emerging safety signals. • Conduct benefit-risk assessments for emerging safety signals and contribute to regulatory responses, labeling updates, and risk management strategies based on scientific evaluation. • Author 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 Clinical Development on safety monitoring activities, Data Safety Monitoring reputed company (DSMB) materials, safety sections of clinical protocols, Investigator Brochures (IBs), and Clinical 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 risk management activities, including Risk Management Plans (RMPs), REMS development, and risk minimization measure effectiveness assessments. • Participate in safety governance bodies, including company safety review committees and cross-functional benefit-risk 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 • reputed company degree required; PharmD, or PhD in a biomedical or clinical 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-risk 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 systematic 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. • Proven 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, clinical 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. Salary reputed company The expected salary reputed company for this position varies by location and will be communicated based on the country or region in which the selected candidate is reputed company. Actual pay will be determined based on experience, qualifications, location, and other job-reputed company 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. • Salary reputed company: $181,000 — $235,000 USD Benefits • 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. Equal Employment Opportunity 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. Reasonable Accommodation 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. reputed company Upon submission of this reputed company I understand that reputed company is based 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. Apply tot his job Apply To this Job