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Medical Information and Pharmacovigilance Specialist, Markham

Created 01/24/2021
Reference 743999732347235
Category Pharmaceuticals
Job type Full Time
Country Canada
City Markham
Zip Not specified
Salary Competitive
Company Description

At LEO Pharma , we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.

Every day, we seek inspiration from people living with atopic dermatitis. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.

Our aspirations are to create an impact through our dermatology expertise and to enhance lives of atopic dermatitis patients. These inspirations are encapsulated in our perpetual quest for the best talent.

Job Description

Are you ready to pioneer together with us? LEO Pharma is looking for the new Medical Information and Pharmacovigilance Specialist who will be an integral part for the successful launch of our new product for the atopic dermatitis.

Working at LEO Pharma:

Reporting directly to the Medical Information and Pharmacovigilance Manager you will be part of a collaborative and innovative community of like-minded specialists connected by mutual respect; a caring culture; and our deep-rooted commitment to advancing the progress of biologic solutions within atopic dermatitis worldwide. Driven by dedication, ambition and agility, we apply our deep knowledge in dermatology and a focus on long-term results.

About your team:

You will join a highly motivated team - competing with the biggest pharmaceutical brands - inspiring one another with bold new ideas, expertise and knowledge to surpass our current size and reputation. With each step of the journey, you will see the impact of your contributions as we flourish and transform into a global leader in medical dermatology

About the Job:

You will provide prompt and accurate responses to Medical Information requests about all LEO Pharma products from internal and external customers, fulfilling all internal and external requirements related to adverse event/adverse drug reaction monitoring and reporting. You will also participate in the review of promotional, training, disease information, and external communications material from a medical / scientific perspective including, but not limited to, medical accuracy of claims and statements, confirmation that claims and statements are appropriately supported by references, and the marketing compliance of the materials in accordance with applicable laws and regulations, LEO Pharma guidelines and industry codes.

Key Responsibilities:

  • Provide high quality, balanced and timely information to requests for medical information from external customers;
  • Prepare and revise Medical Information scientific responses based on available scientific information in medical literature and LEO Pharma data on file;
  • Enter Medical Information requests and responses into the Global Medical Information system;
  • Prepare reports of Medical Information enquiries and activities for key products to share with Patient Solutions Teams;
  • Prepare and conduct training to Sales and Marketing on LEO Pharma products and therapeutic areas;
  • Develop and maintain current knowledge of product disease states, and Canadian regulations pertaining to MIPV practices;
  • Fulfill roles and responsibilities of Deputy Safety Contact Person as described in the Pharmacovigilance Agreement between Global Pharmacovigilance and Deputy Safety Contact Person;
  • Document and process adverse event information from solicited, study and spontaneous reports including basic case entry for all pharmacovigilance cases;
  • Ensure data accuracy, follow-up and reconciliation is completed on pharmacovigilance cases;
  • Support and maintain a local system all pharmacovigilance cases;
  • Receive and initially document product complaints; forward information to the Quality Assurance team for processing;
  • Actively participate in departmental and various cross-functional project teams that may include Regulatory, Sales and Marketing, and Medical Affairs;
  • Understand current brand strategic plans and objectives and provide appropriate input into the development and evolution of these plans and their related tactics;
  • Review promotional, training, disease information, and external communications material for alignment with medical strategy, scientific accuracy / credibility, and internal and external compliance standards;
  • Have an expert understanding of LEO Pharma's internal copy review SOP, policies, and processes and those of external copy review stakeholders (e.g. Health Canada, PAAB, ASC, and IMC).

Qualifications

  • Bachelor's Degree in pharmacy or equivalent, PharmD, MSc. Or Ph.D; and minimum of 1 year of relevant experience or B.Sc. plus minimum 3 years' experience in MIPV;
  • Well-developed written skills (oral and written); Bilingual (French/English) strongly preferred
  • Demonstrate ability to engage and communicate effectively and support customers to drive excellent results;
  • Collaborative approach and team spirit.

Additional Information

Please note that we review applications and conduct interviews on an ongoing basis.

Job Location