Manager, Post-Marketing Pharmacovigilance

About the Role

The Manager of Post-Marketing Pharmacovigilance, reporting to the Director of Pharmacovigilance, will focus on ensuring drug safety for Celcuity’s approved product. This position is responsible for supporting the management and oversight of end-to-end safety case processing and safety reporting activities performed by the external safety vendor.

Responsibilities

• 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 to ensure a high quality of safety case processing is maintained.
• 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 but not limited to PSUR/PBRER and PADER.
• Act as safety liaison between the PV department and internal stakeholders.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in life science (RN, Pharmacist); or relevant experience.
• 4-6 Years of experience years of experience 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.

About Us

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting. The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Pay & Benefits

• Anticipated base pay range: $126,000 - $140,000 DOE
• Annual performance incentive bonus
• New hire equity package
• Medical, dental, and vision insurance
• 401(k) match
• PTO and paid holidays