Senior Manager, Patient Support Program (Vigilance)

Fresenius Kabi USA•Lake Zurich, IL

23h•$159,000 - $165,000•Onsite

About The Position

The Senior Manager, Patient Support Program (Vigilance) is responsible for leading and managing the US Vigilance activities primarily supporting the Biosimilars portfolio within FDA regulations and the procedures and guidelines of Global Vigilance. Develops and executes pharmacovigilance standards for Patient Support Programs, Market Research Programs, product partnering due diligence activities and Risk Evaluation and Mitigation Strategy program for the US Vigilance team. The Senior Manager reports directly to the head of Vigilance and works closely across all departments and areas within Global Vigilance, commercial, legal and alliance management to ensure project, product, and cross functional organization alignment. The incumbent is expected to ensure the Vigilance program meets strategic requirements of the department as well as ensuring the Vigilance activities are consistent and compliant with regional and global strategies, procedures, and regulations. This position requires working onsite 3 days per week at our U.S. headquarters in Lake Zurich, IL. • Salary Range: $159,000-165,000. • Position is eligible to participate in an annual bonus plan with a target of 14% of the base salary. • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Requirements

Bachelor’s Degree required; medical/clinical professional degree strongly preferred (e.g., PharmD, RPh, RN).
8+ years of experience in the pharmaceutical industry, in a drug safety or pharmacovigilance department required.
Experience with Patient Support Programs required.
3+ years of management experience or experience leading successful teams required.
Pharmacovigilance, post-marketed adverse drug event reporting experience required.
Knowledge of PC systems, adverse event databases, and Microsoft Office Suite (Word, Excel) required.
Understands FDA compliance, quality, risk mitigation and planning, and management.
Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events.

Nice To Haves

Advanced degree (PharmD, MS, or MBA) preferred.
Global experience preferred.
ARIS global system experience is preferred.

Responsibilities

Lead all activities relative to pharmacovigilance activities with Fresenius Kabi USA biosimilar business partners, both locally and globally.
Establish relationships, and safety and data exchange agreements (SDEA) with business partners and HUB services, serving as the primary liaison ensuring they meet all global and local regulations, policies, and procedures.
Drive new initiatives, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
Responsible for ensuring the execution and implementation of SDEA, directly supports, and provides oversight of all data exchange and reconciliation activities.
Responsible for oversight of Risk Evaluation and Mitigation Strategy program for biosimilars ensuring execution of program requirements collaborating with vendor and cross functional teams.
Responsible for writing and/or review of applicable Standard Operating Procedures (SOPs). Identifies new procedures needed and changes to be made to established procedures to implement programs.
Ensure that all global and local procedures are in alignment.
Train and mentor staff regarding all established procedures and agreements.
Work cross-functionally within the Global Vigilance team, supporting all PSP Vigilance activities, as needed.
Review and approve adverse event information entered into the global complaint management workflow (gCMW).
Responsible for managing and facilitating the preparation, review, and submission of expedited, as well as non-expedited case reports in accordance with SOPs, as well as domestic and foreign regulatory requirements.
Serve as an Adverse Drug Event (ADE), PV expert, and MedDRA coding expert.