Manager,Pv & Drug Safety

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

Job purpose: 

Manage 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 information on marketed products in order to promote safe, rational and effective use of Taro and TaroPharma products. 

Duties and responsibilities

• Manage all Canadian pharmacovigilance (PV) activities and provide complete adverse event (AE) case management including receipt of AE reports, case follow-up and closure for domestic adverse events in compliance with company SOPs, Canadian and international regulations
• Review marketing literature and promotional materials for accuracy as needed.
• Exchange relevant adverse event, drug safety and pharmacovigilance material with Taro affiliates worldwide
• Provide medical and technical information related to Taro and TaroPharma products to healthcare professionals.
• Manage telephone reports of ADEs/ADRs from consumers, marketing partners, health care professionals, sales & marketing, customer care, regulatory agencies, etc. including necessary follow-up correspondence.
• Develop and conduct medical training for Taro sales force as needed.
• Review relevant medical/scientific literature and prepare required AE reports based on literature sources.
• Prepare and plan Health Canada pharmacovigilance inspection in coordination with QA/QC department to ensure successful results.
• Work with Marketing, providing medical direction in the development and review of promotional material as needed
• Responsible for the preparation of the AE reports for regulatory submissions.
• Communicate effectively with internal staff (e.g., Sales and Marketing) to ensure appropriate use of medical information and drug safety for the benefit of Taro and TaroPharma.
• Perform other related duties as assigned.
• Manage PV/MI (medical information) service provider to ensure compliance to contractual agreement and regulations
• Keep current with drug regulations, revising SOPs and working instructions, and labeling updates.
• Participate in market support activities (including assisting in sales training and product launches) as needed. 
• Review pharmacovigilance agreements with license partners and distributors and ensure timely data exchange with affiliates and partners
• Assessment, investigation, documentation, medical evaluation and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs). Review cases for expectedness and seriousness using either the local Product Monographs or investigator brochures as needed.
• Assess seriousness, expectedness and relatedness to ensure timely regulatory reporting to Health Canada
• Perform 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.

Qualifications

• Strong interpersonal skills with the ability to build strong working relationships with key stakeholders.
• Prior experience in a drug/medical information position, preferably within the Canadian pharmaceutical industry
• Comfortable using PV tools including MedDRA, Medline and Health Canada drug databases.
• Three to Five years related experience.
• Can present medical and technical information in a clear and understandable manner.
• Computer literate and proficient in: Lotus Notes, Microsoft Word and Excel.
• Ability to handle competing priorities.
• Previous experience interacting with Health Canada or other regulatory agencies.
• Strong analytical and research skills.
• Excellent written and verbal communication skills.
• Bachelor of Science Degree in Pharmacy, Nursing, Biomedical Science or Medical Degree.

• Bilingual (French) an asset

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.