About the role:
The Associate Director Pharmacovigilance Operations is responsible for ensuring that all aspects of safety reporting in relation to PAION (both marketed and in development) products are met, PhV responsibilities arising from third party agreements are fulfilled, and overall compliance with documented procedures and regulatory obligations complying to European and ICH guidelines, and globally agreed standards is maintained.
Your tasks & responsibilities:
- Working with the PhV Operations teams (external) to develop and continuously maintain and improve effective systems to ensure correct single case processing and reporting, fulfilling the requirements for signal detection and aggregate report compilation.
- Development and assessment of compliance metrics and ICSR quality control (in co-operation with QA)
- Ensuring compliance with all applicable laws, guidances and business processes
- Acting as subject matter expert for PhV Operations during audits and regulatory inspections.
- Facilitation of issue resolution across functions and partner organisations.
- Delivering and coordination of strategic direction across PAION functions as well as external PhV alliance partners.
- Assisting PV management to drive policy and process changes.
- Assisting in resource forecasting and support PV management in the appropriate allocation of internal and vendor resource to meet fluctuating demand.
- Escalation of relevant issues (e.g., non-compliance, inadequate resources, etc.) to PAION Senior management and assist in their resolution.
- Prompt communication of planned PhV Operations procedural and/or structural changes to key stakeholders.
- Support of PAION QA in the generation and management of the PV training process.
- Bachelor degree in a health science area (e.g. Nursing, Pharmacy).
- Background of working in pharmaceutical/biotechnology industries and service providers (CROs) to those industries with a minimum of 5 years’ experience in PV operations.
- Pre- and postmarketing experience in set-up of PhV processes.
- Knowledge of PhV requirements and legislation for drug development, regional PhV experience.
- Experience in using a defined terminology (MedDRA) for coding of medical terms.
- Advanced level in written and spoken English.
- 30 days vacation (full time)
- Short communication channels, open doors and helpful, committed colleagues
- Flexible working hours with partial home office for a good work-life-balance
- State-of-the-art IT equipment with Dell equipment and Apple iPhones
- New office facilities with employee showers for athletes and underground parking spaces in Aachen in a very good location directly on the A44 freeway
Do you want to work in an international and dynamic environment and would like to play an active role?
We look forward to receiving your application preferably by email, at recruiting@paion.com.
If you have any questions, you can send us an email to HR@paion.com.
For further information please visit our website: www.paionpharma.com
PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.