Senior Manager, Pharmacovigilance

American Regent, Inc.

11d • $165,000 - $185,000

About The Position

The Senior Manager, Pharmacovigilance (PV) will be responsible for organization and managing of activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds. Managing rapid and accurate data entry of AE reports into the safety database, coordinate follow-up as appropriate, maintain knowledge of SOP’s, guidance documents and the safety database under the direction of the Sr. Director, Head of Pharmacovigilance. Essential Duties and Responsibilities • Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions. • Responsible for managing all PV operational activities. • Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs. • Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process. • Coordinate investigations with Quality Assurance (QA) Department. • Provide input into SOPs, updates, and modifications to initiate appropriate changes. • Provide input on end-user’s issue with safety database. • Review of study safety tables and listings. • Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed. • Daily distribution of adverse event reports to drug safety associates. • Complies and distributes monthly reports. • Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list). • Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements. • Answer company queries pertaining to safety database. • Oversees completion of monthly ad-hoc literature searches and yearly contract renewals. • Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues. • Participates in quality initiatives and any associated deviations as needed. • Tracks case processing metrics for monthly reports to senior management/leadership. • Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation. • Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors. • Identify safety signal and coordinate with Medical Directors as to their interpretation. • Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Requirements

• Healthcare Professional, Pharm.D. or related Science Degree, BSN/RN/MSN required.
• Minimum of 8 years of experience in pharmacovigilance within pharmaceutical industry required.
• 3+ years of experience in a supervisory or managerial role required.
• Knowledge of FDA Regulations for industry governing reporting of adverse drug experiences required.
• Knowledge/experiences with handling of adverse drug experiences.
• Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential.
• Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) is required.
• Experience in authoring and reviewing internal documents such as Standard Operating Procedures, maintenance schedules and operating manuals.
• 10% travel required for team meetings and potential audits.

Nice To Haves

• Experience with internal and external audits is preferred.

Responsibilities

• Responsible for receiving and processing AEs reported to American Regent, Inc. from any internal or external source of any product sold or distributed by the company and its divisions.
• Responsible for managing all PV operational activities.
• Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up, and report AEs according to company SOPs.
• Work with individuals in each division and across various departments (regulatory affairs, clinical R&D, medical affairs, and quality assurance) interfaced with the Pharmacovigilance process.
• Coordinate investigations with Quality Assurance (QA) Department.
• Provide input into SOPs, updates, and modifications to initiate appropriate changes.
• Provide input on end-user’s issue with safety database.
• Review of study safety tables and listings.
• Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed.
• Daily distribution of adverse event reports to drug safety associates.
• Complies and distributes monthly reports.
• Oversees PV agreements (completion, revision, and resolution of partner issues, maintains spreadsheets/PV mailbox distribution list).
• Oversees, tracks, and participates in reconciliation process concerning marketed products that are the subject of safety data exchange agreements.
• Answer company queries pertaining to safety database.
• Oversees completion of monthly ad-hoc literature searches and yearly contract renewals.
• Oversees quarterly process for copying of PV files for forwarding to headquarters liaise with cross functional teams such as: QA/RA/Medical Affairs/Clinical R&D for resolution of any PV-related issues.
• Participates in quality initiatives and any associated deviations as needed.
• Tracks case processing metrics for monthly reports to senior management/leadership.
• Prepare SAE narratives and collaborate with CROs/vendors for SAE reconciliation.
• Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs/vendors.
• Identify safety signal and coordinate with Medical Directors as to their interpretation.
• Perform any other tasks/duties as assigned by management.

Benefits

• American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees