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Company Name : Bausch + Lomb
Location : Honolulu, HI 96823
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.
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