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Job Detail

Drug Safety/Pharmacovigilance Senior Associste

Job Summary

Location

Blainville QC

Posting date

Industries

  • Pharmaceutical, Biotechnology

Categories

  • Pharmacovigilance

Role and Responsibilities:

The successful candidate will be responsible to:

  • Provide safety information to healthcare professionals, consumers and medical sales representatives that are relevant, accurate, thorough, referenced and clear in an appropriate format (verbal and written) according to the approved product labelling and internal procedures

  • Respond to requests for information on adverse drug reactions (ADR) post-marketing and in the clinical setting

  • Process case reports according to the internal established procedure and to the federal drug safety regulations

  • Enter all requests for drug safety information in the computerized database system and generate reports as needed

  • Ensure that Duchesnay is compliant with drug safety regulations in the reporting of both expedited and periodic safety reports to the required health authorities in support of our post-marketing drug safety program

  • Liaise with external study centers and clinics regarding safety reports and product surveillance programs

  • Provide support for health authority safety inspections

  • Conduct literature searches and provide summarizes as needed

  • Assist in drafting product labelling (Product Monograph, Health Professional Information, Prescribing Information, Package Insert) for regulatory submissions

  • Contribute to the medical content of promotional materials and websites

  • Multitask on projects across departments including, Regulatory Affairs, Medical Affairs, Research, Business Development and Marketing

Key Skills:

  • Demonstrates technical and scientific skills in the research and interpretation of scientific data

  • Excellent written and analytical skills

  • Excellent communication, documentation, organizational and interpersonal skills

  • Autonomy, ability to work with minimum ofsupervision

  • Ability to adapt and be flexible

Qualifications:

  • Bachelor of Science Degree (nursing or pharmacology related discipline preferred)

  • Minimum 7 years of previous drug safety or pharmacovigilance experience in the pharmaceutical industry

  • Ability to use a computerized database (knowledge of ARISg is an asset)

  • Proficient Microsoft Office and internet skills

  • Bilingual (English/French)