Safety Medical

Nicoleta Pirvuta

lAddress: ** Rue Georges, Dollard des Ormeaux, Québec, H9G 1Z4, Phone: 514-***-**** l Email : ***************@*****.***

PROFFESIONAL PROFILE

Broad expertise in Pharmaceutical industry (pharmacovigilance, preclinical research, drug formulation & development, regulatory intelligence, quality assurance and compliance)

Strong knowledge of the Canadian regulations and international regulations and the proven ability to interpret policies and guidelines

Write, update, and implement Standard Operating Procedures, assist with document control, review of product labels and advertising

Management of sponsors and clients as required by the assigned projects

Team management capabilities, planning and decision making with strong communication and interpersonal skills and the ability to influence and to motivate changes

Produce yearly, quarterly, monthly and other related reports as required by the relevant regulations

Strong analytical and strategic problem-solving skills

Extensive knowledge of drug safety and drug development process and procedures, GMP, GLP/GDP, MedDRA dictionary

In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines

PROFFESIONAL EXPERIENCE

SPECTRUM THERAPEUTICS CANADA (CANOPY GROWTH CORPORATION)

Global Safety Scientist (Drug safety & pharmacovigilance, Regulatory intelligence, Quality assurance and compliance specialist)

April 2019 to April 2020

Extensive contribution to the set-up and maintenance of an efficient Global Pharmacovigilance System

Supporting senior management with research into regulations worldwide to ensure compliance with regulatory developments

Dissemination of new government licensing and reporting requirements, provide regulatory direction and research the applicability of regulations.

Account owner/Safety Subject Matter Expert for PV projects.

Contact for any PV relevant process deviations / non-compliances (NCs) and management of corrective and preventative actions (CAPAs) – for audit and inspection observations – ensuring effective CAPA planning, execution and effectiveness. Conduct routine analysis, trending and feedback to Senior Management.

Provide leadership, manage customers/CRO interface and communication for PV projects

Overseeing and performing PV training of employees.

Responsible for medical assessment, medical review and follow up with patients or HCPs

Reviewing clinical trial protocols and study reports, and presenting as required on safety surveillance issues.

Performs vendor oversight activities by monitoring vendor's case processing quality and compliance metrics

Works closely with medical affairs personnel for PV deliverables related to post-marketing studies/programs

Works closely with Regulatory personnel for regulatory submissions of adverse event reports.

Liaise with Medical Information and Commercial leads to manage vendors and personnel directly involved with PV deliverables

Coordinate with other team members for developing and implementation of the SOP

Examine and compile the Labeling, Advertising and Promotional materials with Regulatory Compliance

Review quality system documents to determine compliance with regulatory regulations and standards

Conduct regulatory intelligence and research on relevant regulatory and advertisement-promotional activities.

Support the quality assurance and quality checking processes of labeling implementation.

Verify and maintain drug labels and packaging updates.

Support the development and implementation of SOPs for the regulation of marketing materials.

Work closely with Regulatory Affairs colleagues to support labeling and advertisement-promotional activities

Ensures development and maintenance of applicable SOPs, Working Practices, PSUR, DSUR and trainings.

Supporting Customer Service Representatives/SPOC Case Managers by performing quality audits and providing feedback and training as required

BRUNEL CANADA ON ASSIGMENT TO SANOFI CANADA

Drug Safety & Pharmacovigilance specialist

December 2014 to April 2019

Receiving, assessing, following up, and entering data of adverse event reports from Spontaneous sources and Clinical Trials into the international safety database.

• Responsible for the Special Access Program which includes assessing requests, communication with physicians to provide information on investigational products, obtaining baseline/follow-up information and collecting and reporting of all adverse events, from this program.

• Reporting of domestic adverse events (spontaneous and clinical) as appropriate to Health Canada.

Receiving and reporting of foreign adverse events (spontaneous and clinical) to TPD/BGTD/MHPD and PHAC as per Health Canada regulations.

• Ensuring that adverse event reports are disseminated appropriately to internal staff.

• Reviewing clinical trial protocols and study reports, and presenting as required on safety surveillance issues.

• Responsible for the Special Access Program which includes assessing requests, communication with physicians to provide information on investigational products, obtaining baseline/follow-up information and collecting and reporting of all adverse events, from this program.

• Proactively and reactively supporting teams who manage product related safety issues

• Collaborating with other members of the Drug Safety team to implement process improvement strategies

MERCK CANADA INC.

Drug Safety Specialist, Pharmacovigilance (PV)

February 2013 to December 2014

Responsible for case management activities for Post marketing and Investigational products in the country.

Assess, review, translate and process spontaneous and solicited/clinical trial adverse events reports, enter them into the safety database

Report adverse events to Health Canada

Conduct follow-ups as required

Conduct reconciliation of adverse events received from other Merck operating units

Assist in preparation for audits/inspections

Train and supervise PV colleagues as needed

Actively contribute to PV processes improvement

Act as a catalyst for team meetings and team collaborations

CHARLES RIVER LABORATORIES MONTREAL

Formulation Scientist (Pharmacy Specialist)

August 2004 – February 2013

Involved in the formulation and process development of various dosage forms and products, development of new products for preclinical formulation studies, validation studies and the preparation of technical documentation.

Full ownership on the development of the final formulation

Formulation designs, development, troubleshooting

Involved in developing analytical methods, experimental methods, method validation, protocols, SOPs, and ensuring compliance with regulatory personnel.

Participate in meetings with project sponsors as required

Perform and document all the experiments and compile all data

Supervise the technical personnel working on the projects

Review patents and literature to identify the best formulation strategies

Issue requisitions for formulations and analytical development testing

Preform all tasks in accordance to SOP's and cGLP's.

CERTIFICATION

Msso’s coding with MedDra training

Rx & D Code of Ethical Practices, 2013

Good Documentation Practice (GDP)

Code of Federal Regulations, Part 11- Electronic Records & Signatures

EDUCATION

University of Pharmacy

Bachelor of Science: Pharmacy

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