Associate, Regulatory

1 month ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**Taro Pharmaceuticals Inc.** is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

What we offer:
A safe and clean; GMP regulated work environment

Opportunities for career growth and development

A competitive wage/salary

Incentive bonus programs that are designed to reward employees for their individual contributions

Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off

Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

Our Brampton location is presently looking for **Associate, Regulatory (Contract)**

**Drug **Safety**:
Assist all pharmacovigilance activities at Taro Canada including Adverse Event (AE) management, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and Signal detection.

Support Taro business objectives by providing timely, balanced and comprehensive Medical Information on marketed products in order to promote safe, rational and effective use of Taro and TaroPharma products. Provide support and oversight in other related Drug Safety activities including Pharmacovigilance Agreements and Product Quality.

**Labeling**:
The Labelling Associate is responsible for the initiation, review and approval of artwork in compliance with Health Canada requirements. In addition the associate will be responsible for preparing and filing the Product Monograph Safety Updates in a timely fashion.

**Duties** **and** **responsibilities**

**Drug **Safety**:

- Perform intake, follow-up and data review of adverse event (AE) cases
- Assessment, documentation, medical evaluation and processing of incoming AE cases. Review cases for expectedness and seriousness using either the local Product Monographs or investigator brochures as needed.
- Review literature screening results to identify AE reports from literature sources.
- Submission of expedited reports to Health Canada.
- Exchange relevant adverse event, drug safety and pharmacovigilance material with Taro affiliates worldwide.
- Performing reconciliation with business partners and vendor for AE report exchanges
- Interact with French Medical Information and AE intake vendor to ensure complete and quality output and provide guidance on follow-up as needed.
- Handling product complaints related to adverse events.
- Provide medical information to customers related to English medical inquires onTaro and TaroPharma products.
- Assist in Health Canada pharmacovigilance inspection in coordination with QA/QC department to ensure successful results

« Assist in quality review for Taro and TaroPharma products on Periodic Safety Update Reports (PSURs), Risk Management Plans and Signal Evaluation Reports to ensure accuracy and completeness.
- Assist in reviewing pharmacovigilance agreements with license partners and distributors and ensure timely data exchange with affiliates and partners
- Assist in developing and conducting AE reporting training for Taro sales force as needed
- Other PV responsibilities as assigned but not limited to the above

**Labeling**:

- Regularly monitor and assess Canadian Reference Product labeling updates and submit PM safety update within the stated timeline.
- Work closely with Artwork Management, Packaging and Marketing departments to facilitate labeling implementation.
- Review internal labelling documentation for adherence to regulatory guidelines.
- Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
- Review and file post approval submissions to Health Canada for revised labelling.
- Prepare written responses to deficiency letters from Health Canada in the stated time frame.

« Assist in the review and development of procedures, guidelines and maintenance system for labelling development, approval and control.
- Ensure documentation is maintained, both hardcopy and electronically.
- Other duties as required by the Man

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