Ana Freitas
Pv Manager @Sanofi
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WORK HISTORY
Pv Manager @Sanofi
Montreal, QC, CA
Ensure smooth operation of case management activities to maintain compliance with corporate and Canadian regulatory reporting requirements. • Assess needs, optimize, and ensure maintenance of the PV procedures according to corporate and Canadian requirements. • Partners with internal and external training teams to drive widespread education in line with international and national regulations and standard operating procedures (SOPs) • Monitor workload and oversee assignment of tasks to ensure compliance with corporate and Canadian requirements. • Compile case management metrics on a monthly basis and analyze/communicate any trends. • Train, supervise and coach PV team on their assigned activities. • Assess needs, organize, and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements. • Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines. Contribute to the development and organization of a local quality system (SOPs) supporting all Pharmacovigilance activities. • Monitor and manage the vendor workload, budget including quarterly meetings• Ensure the quality of the vendor work and address any issues in a timely fashion. • PV team\'s training records management and ensure inspection readiness.and excellent communicator who cultivates strong and positive relationships with business partners.
EDUCATION
McGill University
Bachelor’s Degree, Nursing
Vanier College
DEC in Health Sciences, Health Professions and Related Clinical Sciences, Other
Upskilled
Certificate IV - Occupational Work Health and Safety, Work Health and Safety
Queensland Registered Nurse with AHPRA
Bachelor’s Degree
ABOUT ANA FREITAS
Specialities: Pharmacovigilance Drug Safety Associate, Clinical Operations, Patient Safety, Effective Leader - Operational activities, Regulatory and Drug Safety Compliance, Clinical Trial Research Coordinator, Inspection/Audit preparedness, Essential Document Management expertise, Occupational WHS, Project Coordination and Management, OHS Certificate IV, Nurse Educator, Pharma sales interestCommitment to patient safety and quality in the delivery of health care and health promotion activities.Nursing practice standards and codes of ethics for nurses, WHS Legislation and Compliance activities.The National Health and Medical Research Guidelines, International Conference Harmonization Guidelines for Good Clinical Research Practice (ICH/GCRP), GVP, Government Regulations, Ethical Guidelines, National Statement on ethical conduct in research involving humans, Pharmacokinetics/Pharmacodynamics.Understanding of the applicable FDA, MHPD, and EU requirements related to Pharmacovigilance. Bachelor of Science degree in Nursing Fluent in English (Trilingual- also speak French and Portuguese) Computer knowledgeable, including extensive knowledge of medical and safety electronic data processing systems and applications.Great analytical skills with the ability to effectively identify and resolve problems.Highly motivated with very strong work ethic, energetic and quick learnerExceptional teamwork abilities and also able to work independently.Mid Senior- Manager - Team leader Strong multi-tasking skills and time management skillsAbility to work well under pressure and meet tight deadlines.Proven leadership skillsExceptional written and verbal communication and interpersonal skillsExcellent organizational skills, with attention to detail and excellent data management capabilitiesPersusive communicator who cultivates strong and positive relationships with business partners.
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