You will report to the VP Regulatory Affairs & Quality assurance
PHARMACOVIGILANCE
The main task is to manage the day-to-day operations within the PV department and liaise with the team and management to ensure an effective functioning. This role will be primarily responsible for the quality and compliance of all PV deliverables and be involved in training, business development, audits/inspections, and liaise with the external vendor/QPPV.
Other tasks and responsibilities within Pharmacovigilance include but are not limited to:
-Responsible for plans/instructions and SOPs for post approval surveillance within the company
-Review and approval of processed cases, AE/SAE reconciliation and safety coding as performed by the QPPV.
-Ensure that the handling of SAE in clinical trials and spontaneous reports (ADR) from the market, are collected, forwarded to the QPPV, assessed and entered into the safety database.
-Overview of safety activities in the department as well as those of the QPPV.
-Management of safety communication, if required and requested by the QPPV.
-Quality check of all literature cases and ICSR reports from the territory which are prepared by vendor before medical review step.
-Submit monthly reconciliation reports to the PV department.
REGULATORY SUPPORT
Other tasks and responsibilities within Regulatory support may include but are not limited to:
-Supporting the development of efficient internal regulatory procedures and ways of working to support global product launch and commercialization.
- Supporting the development of efficient working practices with external partners.
- Managing relevant parts of the regulatory maintenance activities potentially including Life Cycle Management and geographic expansion.
-Supporting regulatory & quality inspections and internal audits.
-Supporting artwork development and maintenance in different geographic territories.
QUALIFICATIONS
The right candidate has a Bachelor's degree or higher in Life Science, Pharmacy, Medicine or other relevant filed.
You have minimum of 4 years of documented experience from the pharmaceutical industry including a minimum of 3 years from pharmacovigilance. Previous experience from working in a global regulatory environment is a plus.
Strong computer skills and proficient in MS Office and a perfect command of English language, spoken and written, is an absolute requirement. If you speak Swedish it is advantage.
Further sought for experience includes:
-Experience in team and process set-ups of EU pharmacovigilance environment.
-Experience in internal audits and inspections.
-Knowledge of QPPV tasks like RMP, SDEA, SPC updates, PSMF etc.
- Knowledge and experience in Quality and compliance work.
-Experience in training, coaching, and mentoring other members of staff.
-Experience from work within Regulatory Affairs
