Manager, Post-Marketing Pharmacovigilance

🕒 il y a 11 jours

❄️ Minnesota – Distant

❄️ Minnesota – Remote

💵 $126 000 - $140 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🎡 Marketing

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Celcuity

Site WebLinkedInTous les Emplois

51 - 200 employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Celcuity est une entreprise de biotechnologie en phase clinique développant des thérapies ciblées qui bloquent la voie PI3K/AKT/mTOR (PAM) pour traiter plusieurs tumeurs solides. Son principal candidat, le gedatolisib, est un inhibiteur potentiel de première classe pan-PI3K et mTORC1/2 en cours d'évaluation dans des essais sur le cancer du sein et de la prostate. L'entreprise avance un pipeline ciblé visant à offrir des traitements contre le cancer transformateurs et ciblés et mène un développement clinique et une recherche basée sur les données pour soutenir l'adoption réglementaire et médicale.

Description

• Support vendor management and oversight of end-to-end ICSR collection, processing, reconciliation and safety reporting activities of post-marketing cases performed by the safety vendor • Review safety vendor project plans to ensure processes and procedures are documented appropriately and maintained • Monitor safety vendor deliverables and action items to ensure compliance with timelines • Provide guidance and subject matter expertise to the safety vendor for PV operational activities • Ensure on-time submission of expedited and aggregate safety reports through effective vendor management and routine review of vendor performance metrics • Conduct routine retrospective quality control of safety cases processed by the safety vendor • Oversee reconciliation between safety database and Call Center and other post-marketing sources • Support the development and maintenance of internal PV policies, SOPs, and training programs • Contribute to the preparation and submission of safety reports including PSUR/PBRER and PADER • Act as safety liaison between the PV department and internal stakeholders • Perform other duties as assigned

🎯 Exigences

• Bachelor’s degree in life science (RN, Pharmacist); or relevant experience • 4–6 years of direct pharmacovigilance experience, with a specific focus on post-marketing safety • Deep understanding of FDA guidelines • Experience with Argus, preferred • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels • Strong interpersonal skills for interacting with employees and leaders across various levels and functions • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint • Ability to work in a team or independently as required • Outstanding organizational skills with the ability to prioritize • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization • Flexible and willing to learn; adapting to business and site needs in a dynamic environment • Maintain a positive, approachable and professional attitude

🏖️ Avantages

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays