At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Regional Junior PV Officer
Purpose:
The Regional Junior PV Officer position belongs to the Regional PV Center. The Regional Junior PV Officer contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management, PV process management as well as PV benefit risk management activities. The Regional Junior PV Officer is also responsible for supporting administrative tasks for the PV team within the regional office.
Your Tasks & Responsabilities:
Tasks may include one or a combination of the three areas listed below while focussing on Process Management
PV Process Management
Supports PV process and compliance management by:
- QSD management for local PV teams
- Assisting local PV CAPA management
- Supporting preparation, roll-out and conduct of PV trainings given to local organizations
- Supporting local Pharmacovigilance Contract Management
- Supporting inspection and audit preparation in collaboration with local PV teams and global inspection management
- Supporting generating local Pharmacovigilance System Master Files
PV Case Management
Handles all matters regarding PV cases/Product Technical Complaint (PTC) handling relating (but not limited) to:
- PV case receipt and transfer to Argus where applicable. Identification of PV cases where missing or unclear information is provided and performs clarification as needed.
- Coordination of translation of PV case source documents
- PV case data entry in Argus Safety Database, where applicable, as well as perform quality control of PV cases
- Liaises with the Country Quality Function in relation to PV cases associated with PTCs and aligns on actions.
- PV case reconciliation with internal and external partners.
- Reporting of PV cases to Health Authorities, Investigators and Ethics Committees where applicable
PV Benefit Risk Management
Supports handling of safety topics, signals and contributes to appropriate use of Bayer’s products by:
- Generating Aggregate Safety Reports, e.g. Periodic Benefit Risk Evaluation (PBRER) / Periodic Safety Update Reports (PSURs), Addendum Reports, Bridging Reports, etc.
- Generating local Risk Management Plans
- Adapting global Risk Management Plans to local requirements
- Setting up procedures for local signal detection as well as conducting local signal detection and management as applicable
Who You Are:
- Scientific degree or other relevant qualification related to the area, with less than 1 years’ experience in the Pharmaceutical industry
- Good English language (written and verbal communication)
- Team worker, able to work under tight timelines
- Good communication skills
- Good organizational skills
- Ability to follow and adhere to procedures
Společnost Bayer vítá žádosti o zaměstnání od všech jednotlivců bez ohledu na rasu, národnostní původ, pohlaví, věk, fyzické charakteristiky, sociální původ, zdravotní postižení, členství v odborech, náboženství, rodinný stav, těhotenství, sexuální orientaci, genderovou identitu, vyjádření pohlaví nebo jakékoli nezákonné kritérium podle platných právních předpisů. Zavázali jsme se jednat se všemi žadateli spravedlivě a vyhnout se diskriminaci.
Location:
Czech Republic : Prague : Prague
Division:
Pharmaceuticals
Reference Code:
795252