Senior Pharmacovigilance Specialist

Bausch Health is a global company that develops, manufactures and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

The Senior Pharmacovigilance Specialist will be responsible for post marketing and clinical trial safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations. You will work in close collaboration with external vendors and affiliates to ensure that individual case reports for pre-and post-marketed products are properly produced, exchanged, and submitted.

This role is open to US Citizens or Canada Citizens.

RESPONSIBILITIES:

• Provides oversight and support for external safety data processing provider ensuring high quality and compliant individual case safety report processing.

• Review and approve adverse event reports for pre- and post-marketed product: clarify medical issues, ensure clear narratives, revise MedDRA terms, and coordinate with external vendor and internal medical personnel as needed.

• Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.

• Respond to internal and external stakeholders on case processing queries.

• Represent the Pharmacovigilance department on clinical project meetings and perform clinical trial support activities relating to drug safety, as required.

• Inform Manager/Director of safety related issues and potential trends and or signals arising from review of pre and post marketed safety data.

QUALIFICATIONS:

• 3 years of Pharmacovigilance experience MANDATORY

• BS/MS/Doctorate degree in health science or health care related field

• 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

#LI-Remote

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

We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

Any exception will have to be authorized by your HR Business Partner.

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

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 Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

Bausch Health is an EEO/AA employer M/F/D/V.