PV Specialist
- Permanent
- PVG & Drug Safety, Global Drug Safety
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a PV Specialist to join a leading global biopharmaceutical company that has been inventing for life for more than a century. This position is based in the country Pharmacovigilance department and you will be responsible for the day-to-day case management activities within the country's covered by the country operation.
Job Responsibilities:
- Procedural responsibilities in the areas of: Adverse experience case management including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports.
- Responsible for day-to-day adverse experience case management within the countries covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per the organisation's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
- Responsible for the reconciliation of adverse events reports received from other of the organisations operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
- Responsible for the filing, storage and archiving of safety-related data in accordance with the company's policies and local requirements.
- Accountable for being compliant with local PV regulations, company policies and procedures and Global Safety procedures at the country level.
- Partake in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the countries covered by the country operation.
- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
- Recognise and communicate potential safety issues to PV Country Lead.
- You will assist in the training and mentoring of PV staff as applicable. Complete and document required PV training within the required timelines.
- As requested by the PV Country Lead, the PV Specialist may undertake other additional activities including projects.
Key Skills:
- Strong communication and time management skills.
- Ability to work independently with minimal supervision.
- He/she is able to function independently in the processing of adverse events.
Requirements:
- Must have a health, life science, or medical science degree or equivalent by education / experience.
- A minimum 1 year of pharmaceutical industry experience.
- Must have an awareness of pharmacovigilance regulations within his/her assigned countries.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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