Pharmacovigilance Specialist Ii

2 weeks ago

Laval, Canada Bausch Health Companies Full time

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

**Objectives / Purpose of the Job**:
Post marketing and clinical trial safety activities, ensuring that Adverse Events are identified and processed in accordance with international regulations.

Working in close collaboration with Bausch Healths vendors and affiliates to ensure that individual case reports for pre
- and post-marketed products are properly produced, exchanged and submitted.

**Key Activities / Responsibilities**:
Provide oversight and support for external safety data processing provider ensuring high quality and compliant case processing.

Review and approve adverse events report for pre
- and post-marketed products: clarify medical issues, ensure clear narrative, 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.

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/or signals arising from review of pre
- and post
- marketed safety data.

**QUALIFICATIONS**:

- Education: University degree with Pharmaceutical, Medical or Scientific background (Pharmacy, Nursing, DESS)
- Experience: Minimum 2years of Pharmacovigilance experience.
- Knowledge/Skills:

- Understanding of International Pharmacovigilance regulations.
- Understanding Health Canada Pharmacovigilance regulations and guidelines.
- Excellent oral and written communication skills in French and English.
- Excellent interpersonal skills and willingness to work in a team environment.
- Demonstrates consistent attention to detail; highly organized and demonstrates understanding of workflow prioritization.
- The masculine is used in this publication without prejudice for the sake of conciseness._
- Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates._

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

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