Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Reference Data Maintenance Expert
The job holder works in a team of PV experts who are analyzing and maintaining PV reference information and establish technical configurations of computerized global PV systems and other global satellite systems (like SDRA).
The job holder works in close co-operation with many global PV business functions and IT functions to ensure that the global PV systems are kept consistent, operational and fit for purpose.
This includes the setup and maintenance of the dictionaries for products, studies and registration information as well as electronic datasheets for auto-labelling and code lists containing other data of relevance for the PV business.
The job holder’s role also includes the responsibility to mitigate any compliance risks, with a special focus on consistency and correctness of Reference information.
Major tasks and responsibilities
- Responsibility to keep the computerized PV System operational and fit for purpose. Supervises the maintenance of all Reference Data (reference tables) used by the system and the regular reconciliation of this data with other sources (e.g. BRAIN/BRAVE, Impact, PV Agreements with License partners).
- Steer the maintenance of the PV safety database (Argus) dictionary of all products and licenses including development products and licenses. This includes the definition of cross-reporting needs as well as the maintenance of datasheets for auto-labelling in cooperation with PV Benefit Risk Management and PV Analytics.
- Responsibility for maintaining the dictionary of all studies including non-company studies for which PV will have to process SAE reports (e.g. investigator led studies). For every study the referenced study medication must be defined and maintained (before and after unblinding if applicable).
- Significant contribution to the maintenance of a centralized PV reporting process for all international health authorities, notified bodies and license partners. This includes compliance analysis and CAPA handling in case of incompliant reporting.
- Significant contribution to and general oversight of case distribution matrix processes. This includes the list of all reporting destinations as well as the reporting rules per recipient (local PV through Affiliate Module, external partners, study teams etc.). The distribution matrix contains all case distribution rules for regulatory reporting purposes as well as the distribution needs for SUSARs notifications to investigators and Ethics Committees / IRBs and any further distribution rules, e.g. to clinical study teams.
- Contribution to required PV systems changes, incl. preparation and execution of Change Controls (like IQ, OQ, PQ)
- Contribution to establishment of global PV data interfaces for the computerized
global Pharmacovigilance System with partnering systems, and technical consultancy on PV processes, especially related to PV data exchange.
Who you are
- Pharmaceutical degree or master's degree in life sciences, with several years of pharmacovigilance or clinical experience or relevant Bayer Pharmaceuticals experience
- Significant experience with maintenance of a PV product dictionary and related data
- Profound knowledge of global regulations and guidelines, especially to vaccines
- Extensive knowledge of drug safety processes, especially to vaccines
- Proven ability to work in a very structured and accurate way
- Experience & willingness to manage relationships with internal staff and external service providers.
- Excellent oral and written communication skills in English
At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Reward is important to us, employees benefit from excellent employment conditions, such as:
- competitive salary and performance bonus
- 25 days annual leave plus bank holidays
- Private Healthcare, generous pension scheme and Life Insurance
- Employee discount scheme
- State of the art offices
- International career possibilities
- Flexible working
Are you up for the challenge? If so, please apply below.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 440806
Functional Area: Medical Affairs & Pharmacovigilance