Senior Specialist Pharmacovigilance (14-month fixed-term contract)

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Senior Specialist Pharmacovigilance (14-month fixed-term contract)

ESSENTIAL DUTIES AND RESPOSNIBILITIES

Activities related to the Slovenia and CEEI

1.Local PV system

·Identifying, implementing and maintaining local processes and documents (procedures, instructions) building an efficient local pharmacovigilance system meeting local, national requirements and in compliance with Baxter pharmacovigilance procedures.

·Contribution to quality management system.

·Contribution to EU PSMF.

·Knowledge of legislation and impact assessment/gap analysis on Baxter PV system.

2.Cooperation with vendors

·Managing all activities connected to services provided by vendors incl. training in the assigned countries.

3.AE reporting

·Receipt of ICSRs and any other reportable information from any source, documentation, follow-up (if needed with special forms) and registration in global database in accordance with global Baxter procedures and within timelines.

·Checking the database on daily basis.

·Quality check of assigned cases.

·Submission of ICSRs to relevant local CAs/partners timely and according to local requirements. Answering subsequent questions from local CAs in collaboration with regional PS director.

·Reconciliation of ICSRs with all relevant partners acc. to and within timelines specified in SDEAs.

·Answering questions from HCPs with support or GPS and in collaboration with regional PS director.

·Answering questions and requests from GPS in timely manner.

4.Training

·Training on PV of Baxter new employees upon their arrival and Baxter customer-facing employees on yearly basis or as needed by local regulations.

·Train on PV any third party bounded with Baxter with safety agreements and with agreed frequency as indicated in agreement.

·Archive training documentation.

·Keep up to date own training records.

5.Safety agreements

·Awareness, overview of safety agreement with Baxter partners in countries of responsibility and fulfilment of specified activities including but not limited to exchange of ICSRs, trainings and periodic reconciliation.

·Review of local SDEAs as per internal process.

·Impact assessment of changes in SDEAs on PV system.

6.PSURs, RMPs, PASS, PSP/MRPs

·Having overview and access to current local PSUR schedule from regulatory affairs.

·If needed and according to established local process validate comparative table prepared by regulatory in order to put CCDS/CCSI/RSI and local SmPC in conformity.

·Awareness, overview of and review of safety sections local PSP/MRPs, RMPs, PASS-protocols and fulfilment of specified activities if applicable locally for example risk minimization measures to be implemented locally.

7.Interactions

·Ensure appropriate contact with country head/cluster general manager, and other interfaces not limited to country regulatory affairs, country quality assurance, business units and with healthcare professionals and local competent authorities.

·Bringing safety expertise and advice to other local functions when needed.

8.Local safety issues/safety signals

·Review local safety communications.

·Participation in all safety issues with products in countries of responsibility, emerging safety concerns, safety variations.

·Assessment of signal applicability and sending communications to CAs/partners, as needed.

9.Audits and inspections

·Act as contact point for inspections by Slovenian and local CAs. Leading/participation in internal audits as per plan.

10.Compliance

·Monitor and ensuring local compliance, make efforts to achieve high compliance rates.

·Participation in CAPA, initiation and FU of CAPA.

11.Local literature searches

·Monitoring of local journals in Slovenia and assigned countries.

12.Activities related to other countries in CEEI&META region

·Provide support to CEEI&META countries in different aspects of pharmacovigilance when needed and required.

·Close collaboration with CEEI&META team.

QUALIFICATIONS

·Knowledge of PV regulations and PV databases

·Ability to work with cross-country and multicultural team.

·Attention to detail.

·Strong collaboration skills and ability to work in virtual environment.

·Ability to work under strict timelines.

·Very good communication skills

·Experience in working in a multinational team environment.

EDUCATION AND EXPERIENCE

·Academic degree in pharmacy or medicine.

·2+ years of experience in the field of Pharmacovigilance.

·Language skills- fluent in Slovenian and English, knowledge of other languages Croatian, Serbian, Bosnian would be advantage.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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