Director, Pharmacovigilance Job Vacancy in Bausch + Lomb Billings, MT 59101 – Latest Jobs in Billings, MT 59101

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Company Name : Bausch + Lomb
Location : Billings, MT 59101
Position : Director, Pharmacovigilance

Job Description : 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 peoples lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

JOB TITLE

Director, Global Pharmacovigilance and Risk Management

BUSINESS TITLE

Director, Global Pharmacovigilance and Risk Management.

BAND

Director

BUSINESS UNIT / FUNCTION

Global Pharmacovigilance and Risk Management

JOB CODE

LOCATION

Bridgewater, NJ, USA

OBJECTIVES/ PURPOSE OF JOB

The Director, ICSR Processing is responsible for providing direction and oversite for all individual case safety report (ICSR) processing and submission of post-marketing and clinical trial safety activities, ensuring that reportable adverse events are identified and processed in accordance with global regulatory requirements.

Manage global case processing vendors, ensuring high quality and compliance.

KEY ACTIVITIES/ RESPONSIBILITIES

Oversee and manage the review, submission and reconciliation of all individual case safety reports to ensure high quality and compliance.

Manage and develop Global ICSR team.

Coordinate with external vendor and internal medical personnel as needed.

Provides oversight and support for external safety data processing provider, ensure efficient and cost-effective services.

Coordinates product safety oversight activities.

Assist team and senior management in all forms of safety issue management and mitigation.

Analyze metrics for critical department processes to ensure compliance with SOPs and regulatory requirements.

Formulate and implement improvements and enhancements as needed, including procedural and technical advancements.

Represent GPRM in interactions with key internal departments including Regulatory affairs, Clinical R&D, Quality Assurance and Medical Communications.

Inform Risk Management department when aware of any safety related issues and potential trends and/or signals arising from review of pre and post marketed safety data.

Manage PV CAPA related to case processing, submission and reconciliation.

JOB DESCRIPTION

SUPERVISE DIRECT REPORTS

(yes or no)

No

SCOPE OF POSITION

Member of Global Pharmacovigilance and Risk Management group who interacts with all internal and external stakeholders involved with the processing and reporting of individual case reports.

Management of ICSR workflow in the Safety database to ensure ICSR compliance

PV CAPA management activities

KEY RELATIONSHIPS

Internal: ICSR team, Regulatory Affairs, Clinical R&D, Quality Assurance and Medical Communications.

External: PV vendors and Business Partners

QUALIFICATIONS/ TRAINING

Knowledge/Skills: Global clinical safety and pharmacovigilance regulations and guidelines; Use of safety database, preferably ARISg; Working knowledge of scientific terms and medical terminology; Excellent oral and written communication skills; Excellent interpersonal skills and willingness to work in a team environment; Demonstrates consistent attention to detail; Highly organized and demonstrates understanding of workflow prioritization and resource allocation.

Education: BS/MS/Doctorate degree in Pharmacy or Nursing, or related discipline or comparable field of study from an accredited college or university.

Experience: Minimum 10 years in pharmaceutical industry with at least 7 years in drug safety/pharmacovigilance, 5 of which must be in a management position.

This position may be available in the following location(s): [[location_obj]]

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.

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