Job Description

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.

Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit: www.taro.com.

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

\xc2\xab 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.

\xc2\xab 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 Manager.

Qualifications

• Degree in Life science, Nursing or Pharmacy or other health-related field or equivalent qualification with at least two (2) to five (5) years of relevant experience within a Canadian pharmaceutical environment.
• Good communication and writing skills
• Working knowledge of Argus application
• Strong knowledge of MS Office (Word, Excel, PowerPoint)
• Minimum of two years of PV experience in pharmaceutical industry
• Familiar with Health Canada regulations and ICH guidance
• Strong attention to detail
• Must possess the ability to work effectively in a fast-paced environment, and deal effectively with changing priorities
• Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
• Strong organizational ability to maintain a complex and high volume of technical information up to date
• Ability to plan, coordinate and work effectively in a team-oriented environment.
• Fluency in French an asset.

Physical requirements Office based role

We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.

This position is open to applicants legally authorized to work in Canada.

Taro Pharmaceuticals Inc. embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We ensure that our recruitment practices are supportive of this commitment and do not infringe on any characteristics protected by law.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, and the Ontario Human Rights Code, Taro Pharmaceuticals Inc. will provide accommodation throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

NOTE: All employment is conditional upon the completing and obtaining of a satisfactory background check which may include educational, employment, references and criminal records (for which a pardon has not been granted) checks.

AGENCY NOTICE: Please note that Taro Pharmaceuticals Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with an agency / recruiter, Taro Pharmaceuticals Inc. will not consider any referrals or agree to payment of referral or recruitment fees. In the event a recruiter or an agency submits a resume or candidate without a previously signed agreement, Taro Pharmaceuticals Inc. explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Sun Pharmaceutical Industries