Pharmacovigilance Database Director

Date: Jul 28, 2022

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch & Lomb

Bausch+Lomb Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch+Lomb products are used by over 150 million people around the world.

 

Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries. 

 

JOB TITLE

 

PV Database Director

BUSINESS TITLE

PV Database Director

BAND

 

BUSINESS UNIT / FUNCTION

Global Pharmacovigilance and Risk Management

JOB CODE

 

LOCATION

Bridgewater, NJ

OBJECTIVES/
PURPOSE OF JOB

Under the supervision of the Head of External Relations, this

position will assume responsibility for the maintenance of the Global Pharmacovigilance Safety System (database) including but not limited to, liaising with the safety database vendor participating in User Acceptance Testing (UAT) Phase of new system implementations, system upgrades, data migrations, conduct safety system training, maintenance of Company Product Dictionary, distribution rules, safety system testing, and ensuring the Global PV safety system management responsibilities and requirements are being met. 

Responsibilities also include maintenance of a signal detection application, agreements database and other PV/Safety systems used by the GPRM department.

Provide guidance and assistance in the implementation and update of departmental procedural documents related to databases and tools.

This position will be the primary point of contact between the company and the safety database vendor.

KEY ACTIVITIES/
RESPONSIBILITIES

-Lead new system implementations, system upgrades, product divestures, data migrations, etc.

-Responsible for preparing UAT scripts, UAT Protocols, UAT Summary Reports for system upgrades and/or new system implementations.

-Assist in ARISg Database Training in database Validation and Production environments for new users, as applicable.

-Review database vendor's Operational Qualification and Installation Qualification scripts, as applicable.

-Responsible for Change control process of ARISg, other safety systems and applications and Service Tickets.

-Responsible for maintenance of the Company Product Dictionary.

-Responsible for the creation and maintenance of Partner and Health Authority Distribution Rules.

- Manage database team with direct reports.

- Act as liaison and primary point of contact between the business and database vendors.

- Master and maintain up-to-date knowledge of the US Federal Regulations and Guidelines governing the reporting of investigational and post marketing adverse events.

- Master and maintain knowledge of the ICH regulations and guidelines governing the global reporting of adverse events on investigational and/or marketed products (particularly ICH E2A, E2C and E2B).

- Perform other pharmacovigilance activities related to External Relations and other functions.

- Proactive application of safety database knowledge to company specific challenges in safety reporting

SUPERVISE DIRECT REPORTS

(yes or no)

Yes

  1. OF POSITION

Perform above activities for Global Pharmacovigilance and Risk Management as they relate to the oversight of electronic systems in use by the company to ensure patient safety and regulatory compliance.

KEY RELATIONSHIPS

 

Database Vendor(s)

PV Vendor

GPRM Functional Teams

QUALIFICATIONS/
TRAINING

 

 -Knowledge of ARISg safety database preferred.

-Drug safety systems and applications: 5 years.

-Solid understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements.

-Proficiency with basic MS Office applications. Advanced Microsoft excel skill is preferred.

-Project management and multitasking skills.

-Understanding the importance of documentation requirements in a regulated environment.

-Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment.

-Ability to work under pressure to meet tight deadlines.

-Good interpersonal skills (i.e. team player).

-Strong attention to detail along with the ability to meet deadlines.

-Ability to work well in a matrixed, global team environment.

-Prior experience managing people is preferred.

  

 

This position may be available in the following location(s): US - Bridgewater, NJ

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.