Sr. Manager Pharmacovigilance - remote

Position can be fully remote

PURPOSE AND SCOPE:

Responsible for the management and oversight of product complaints. Ensures processes and systems are established and effective to receive, review, and interface with plants for investigation. Reviews for closure various product complaints which include reportable complaints and/or litigation complaints. Responsible for the maintenance of the complaint database system to track and store Quality System records and complaint files. Helps provide customer support and serves as liaison between manufacturing facilities, Post Market Clinical, and customer/patients regarding potential product problems.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

• Ensures corporate compliance with adverse event reporting requirements; interprets the medical significance of all incoming safety information.
• Actively coordinates with the Director of Pharmacovigilance and Post Market Surveillance in the daily management and execution of pharmacovigilance (PV) operations for Pharma Product Complaints that are associated with adverse events.
• Provides oversight for the adverse event (AE) reporting activities for delegated products and/or projects.
• Serves as a Team Leader within the pharmacovigilance department supervising employees (i.e., Drug Safety Specialists and PV Principal Scientists) to validate data entry for preparation of Individual Case Safety Reports (ICSR’s) in the safety database and overall responsible to ensure all aggregate reports and ad-hoc internal and external safety queries preparations are carried out with high quality as per good PV practices.
• Reviews incoming AE information to determine required action based on internal policies and procedures including identifying follow-up on clinically important adverse event reports.
• Ensures corporate compliance with international adverse event reporting requirements for delegated products.
• Collaborates with the PV Physician and Director of Pharmacovigilance and Post Market Surveillance as the lead for signal detection/safety monitoring activities which involves extracting relevant line listings of all AE’s from the PV system through MedDRA queries and present safety data to internal stake holders during monthly and/or annually meetings as needed
• Initiates processing and revision of all PV standard operating procedures (SOP) and work instructions (WI) for efficient PV practices, as per regulations
• Collaborates with the PV Physician and Director of Pharmacovigilance and Post Market Surveillance as the lead in the authoring and preparation of relevant safety documents. This includes writing detailed safety analyses and summaries including signal evaluation reports; regulatory reports such as US periodic adverse event reports (PADER), periodic safety update reports (PSUR), as well as in the preparation of other relevant documents such as pharmacovigilance plans and regulatory approval filing documents.
• Ensures compliant exchange of safety data between FMCNA and its other partners.
• Collaborates with the contract service providers for all interlinked PV processes.
• Assists the Director of Pharmacovigilance and Post Market Surveillance to co-chair the Drug Safety Review Board meetings, as needed
• Monitors the safety profile of delegated products and collaborate with the Director of Pharmacovigilance and Post Market Surveillance to assist in recommending appropriate action(s) including labeling amendments and risk management programs when warranted to the appropriate stakeholders.
• Evaluates the clinical implications of safety data from literature and other information sources in order to establish the safety profile of drugs to manage the risk to patients.
• Collaborates with contract service providers for case processing aggregate reporting and quality management activities.
• Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
• Takes a lead collaborating with Director of Pharmacovigilance and Post Market Surveillance in regulatory inspections and audits
• Provides training to staff to improve efficiencies on PV work processes
• Develop relationships with and capture drug safety information from key groups
• Ensures compliant exchange of Safety Data Exchange between FM-NA partners and affiliates
• Takes a lead in preparation of Regulatory PV inspections and Audits to ensure all PV procedures at FMCNA are fully compliant with Good Pharmacovigilance practices and prepares responses to PV audit findings in collaboration with the Director of Pharmacovigilance and Post Market Surveillance.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISION:

Responsible for the direct supervision of various levels of Post Market Surveillance staff.

EDUCATION:

Bachelor’s Degree required, preferably in Science or Healthcare related field. RN degree preferred, BSRN strongly preferred.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 6 – 8 years of related product complaints experience required; 3+ years of experience managing product complaints in the Medical Device Industry preferred.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Demonstrated ability to manage one or more departments.
• Requires advanced understanding of regulatory obligations for compliance within the scope of the department.
• Matrix management experience preferred.
• Knowledge of FDA and ISO post-marketing requirements.
• Experience in the Health Care Industry (Nephrology) communicating with medical personnel.
• Prior experience with system level complaints and/or litigation complaints a plus.
• PC based computer skills: especially data management systems such as Access and Excel.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.