Manager, Post-Marketing Pharmacovigilance

🔥 1 minute ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $126k - $140k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎡 Marketing

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

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