Nienke Barbara Feo Anero

Managed and coordinated projects to take over comprehensive pharmacovigilance responsibility for a company’s medicinal product(s) in the post-approval phase. Led project for the set up and management of PV Agreements. Screened scientific literature for safety-relevant publications and screened European PV websites for new findings. Supported the QPPV in conducting signal management activities. Maintained Pharmacovigilance System Master Files (PSMFs), including reviewing.

Responsible for the area of anti-infectives and parenteral nutrition products as registered information officer according to §74a AMG: Coordinated internal review processes among cross-functional departments including Marketing, EU-QPPV - Pharmacovigilance, Regulatory Affairs, Quality Assurance, Medical department, and Supply Chain. Reviewed promotional material and information on institutional websites in accordance with compliance provisions of HWG, AMG. Coordinated non-interventional studies.

Practical work as part of the advanced training “Clinical Research / Clinical Monitor”: Business Continuity Plan (24/7) -Project Management and support. PV Agreements -Project Management and support. Individual Case Safety Reports, ARGUS Database, MedDRA,D2C Launch, PSURs –Process Insight. Patient Support Programs, Audits & Inspections. SafetyRelevant Reports Generation, Post authorisation safety studies. Presentation of Study Results and Safety Profiles of single drugs.

Controlled and assessed drug prescriptions, potential interactions, errors in dosage and contraindications.Documented regulated medications, specifically narcotics; controlled pharmacovigilance report cards of side effects.Contacted and communicated doctors, provided individualized pharmaceutical assessment, and personalized patient care.Personnel management (3 PTAs and 2 PKAs): Organized and planned personnel forecast and distribution of tasks within the team.

Conducted pharmaceutical and administrative control; worked on cases that needed clarification from the order department. Provided feedback to supervisors in case of risk and unavailability of the service level agreement. Efficient processing of new orders, adhering to pharmaceutical inspection specifications.

Dispensed and replenished medications. Controlled and assessed drug prescriptions. Provided pharmaceutical care to patients.

Performed pharmaceutical compounding; examined clinical analyses; controlled enteral nutrition and parenteral prescription, such as cytostatic. Controlled pharmacovigilance reporting cards of interactions. Researched use of new technologies in hospital settings to avoid medication errors.

Advanced Training as “Pharma Business-Process Management” - HGA Gesundheitsakademie Hessen, Germany Certificate: Pharmaeconomics Goals ongoing: Quality Management, Quality Assurance, Good Manufacturing Practice, Good Clinical Practice, Clinical Research, Project Management, Pharmaceutical Process Management.

-Drug safety -ICH-GCP, AMG guidelines -EDV-Applications clinical trials -Medical basics and medical terminology -Pharmacological / toxicological basics -Medical statistics and biometrics -Project management

Specialized in pharmacology & nutrition Main fields of study: Social and Legal Aspects of Pharmacy, Clinical and Medical Analysis, Plant Biology and Pharmacognosy, Pharmacology and Clinical Pharmacy, Microbiology and Parasitology, Morphology and Functions of the Human Body, Chemistry and Biochemistry and Pharmaceutical Technology, Nutrition.