Anna Bussel Email & Phone Number

Southborough, Massachusetts, Us

• Assumes the responsibility for the overall day-to-day management of the PV and MI department. • Provides pre-approval and post-market pharmacovigilance consultancy for pharmaceutical drugs (brand and generic), biologics, radiopharmaceutical drugs, natural health products, medical devices, and cosmetics (including Risk Management Plans authoring, periodic safety reports critical analysis and signal detection). • Plays a critical role in ensuring positive client interactions and leading complex Pharmacovigilance and Medical Information activities on behalf of the Company and client. • Involved in quote preparation, project reviews, and providing support to Business Development.• Conducts GVP Auditing and participates in Health Canada inspections.• Qualified Healthcare professional

Southborough, Massachusetts, Us

• Responsible for the direct management of assigned PV and MI staff.• Participated in strategic decision making for PV and identifying departmental needs and implementing efficiencies.• Effectively manage PV and MI projects and cultivated strong, positive relationships with clients.• Processed Individual Case Safety Reports, including conducting a medical evaluation of cases, assessments of reportability to health agencies, and preparation of company comments.• Authored and provided a medical review of aggregate reports (i.e., critical analysis and medical conclusion as well as recommendations for safety actions/monitoring, if applicable).• Authored and provided input into and assistance with Risk Management Plans.• Conducted signal detection and management and recommend actions.• Conducted GVP auditing of clients’ and/or clients’ contractual partners/vendors to ensure regulatory and contractual compliance.• Assisted with business development activities.• Led and participated in corporate compliance activities as they related to PV.• Led cross‐functional collaborations and liaised with key internal/external stakeholders.• Qualified Healthcare professional.

Southborough, Massachusetts, Us

Joined as PV and Medical Information associate I and was promoted to PV and Medical Information manager over time.• Provided pre-approval and post-market pharmacovigilance consultancy for pharmaceutical drugs (brand and generic), biologics, radiopharmaceutical drugs, natural health products, medical devices and cosmetics, including: • Individual Case Safety Report Processing, including coding, medical evaluation, assessment of reportability to health agencies, and preparation of company comments (FDA and Health Canada) • Follow-up with reporters of safety information (when applicable) • Aggregate Reports preparation (PSUR, PADER and PBRER), including critical analysis and the medical conclusion • Screening of the worldwide and local literature • Screening of the Canada Vigilance adverse reaction online database • Assistance with Risk Management Plans • Signal Detection and Management • GVP Auditing • Provided Medical Information services and manage product complaints • Built strong relationships with vendors (as project lead) • Prioritized workload for assigned projects depending on the internal and external deadlines • Introduced regular team meetings for best practices exchange and experience sharing. • Provided trainings as required. • Performed Regulatory intelligence activities. • Qualified Healthcare professional

• Drafting of the regulatory content for the submission, e.g. labeling documents, LOA, declarations. Coordination of translations, legalizations.• Defining the content of the submission, assuring final consistency in content, format and wording across the entire submission.• Appropriate planning and meeting of submission deadlines.• Labeling dependencies and CCDS updates support.• Launch and Withdrawal regulatory assessments.• Drafting responses to deficiency letters and HCP requests. • Types of procedures covered: Renewals (International countries), Variations (CMC, Labelling, Worksharing), PSUSA.

Indianapolis, Indiana, Us

Joined as Medical and regulatory assistant and promoted to Regulatory, Drug Safety and Quality Manager (Head of department) over time. • Regulatory affairs activities (obtained timely approvals for drug product & device (Regulatory project management of new drug application, renewal, product life cycle compliance maintenance); Labeling responsible person); responsible for materials (standards and samples) and equipment handling for registration purposes; developed Standard Operation Procedures (SOPs) for regulatory, product quality and PV local quality system, reviewed regional regulatory SOPs; developed and delivered onboarding and refreshing training). • Quality activities (Product Quality responsible person (complaints, withdrawals and recalls); change control, deviations, CAPA and Quality plan management; quality oversight of current and perspective vendors including database maintenance and onsite quality inspections, Key Performance Metrics establishment, assessment, and trending. Reviewed and adjusted the finished product quality agreement in regards to GDP and local regulation; coordination of the analytical testing for both product release at importation and registration purposes). • Qualified/Contact Person Responsible for Pharmacovigilance, Primary point of contact for adverse events and product complaints reporting from Healthcare professionals, vendors/consumers and Health Authorities (drug safety operations including but not limited to expedited and periodic reporting management, adverse event (ADR/AE) and product complaints processing (reports from spontaneous sources, scientific literature, clinical trials and post-marketing studies) and submission to Health Authorities; developed PV sub-system master file.Obtained practical experience with Argus, SAIL, Blue!, Salesforce, BOX, SharePoint, TrackWise, Regulus, Veeva, ColdStream, Securimate, TVT, SAP (beginner), advanced skills in MS Office software, Adobe Acrobat Pro.

Indianapolis, Indiana, Us

• Performed assigned regulatory, pharmacovigilance, and product quality activities. • External networking (Liaised with external stakeholders regarding market access; participated in working groups of industrial organizations and Regulatory agencies; established and strengthened contacts with key external stakeholders ). • Internal networking (Coached the medical and regulatory team (3 people) and introduced effective cost-saving activities in department's budget management; led cross-functional cooperation including Kaisen project; developed and implemented management acknowledgment tool pertaining to new legislation impact interpretation; responsible for regulatory intelligence activities; introduced e-archiving in the department). • Medical activities (provided back up support, including medical information services, promotional materials verification). • Provided support to Clinical operations (support with clinical study application documentation, Investigators’ Brochures, local informed consent forms). • Served as responsible for Anticorruption activities (over 30 Third parties required anticorruption monitoring per year); provided support to meeting and events arrangements being responsible for company grants and donations requests management).

Project Management

Diploma With Distinction, Pharmaceutical Regulatory Affairs

Certificate, Pharmacy Assistant

Master Of Science - Ms In Pharmacy, General Pharmacy