Manager, Post-Marketing Pharmacovigilance

Reporting to the Director of Pharmacovigilance, the Manager of Post-Marketing 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.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $126,000 - $140,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity's receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.