Senior PV Manager (remote-based)
7 days left
- Experience Level
Hobson Prior are currently working with a leading CRO who are recruiting for a Senior PV Manager to join them on a permanent basis, where you will be required to work remotely. Our client is focused on providing clinical development solutions for the biotech and pharmaceutical industries.
- Accountable to lead the pharmacovigilance team.
- Maintains awareness of and adherence to the schedule of established project and process timelines.
- You will establish and measure set of metrics applicable for PV performance.
- Manages the budget of the pharmacovigilance services.
- Develops Safety Management Plans for the clinical trials.
- Provides inputs to project design, establishes and implements the project's safety strategy.
- Prepares and maintains Standard Operating Procedures fulfilling all relevant law regulations and describing an appropriate and effective pharmacovigilance system.
- Develops and improves working instructions, guidelines, standards for PV team covering case processing (case review, quality control, electronic database entry, follow-up activity, queries and narrative writing, reconciliation), safety reporting (preparation, quality control and submission of periodic and expedited reports to Competent Authorities, Ethics Committees).
- Assists sponsors in Development Safety Update Report writing, compilation and submission of the report to the competent authorities within the time frames declared by the pharmaceutical laws and effective regulations.
- Initializes urgent actions whenever required.
- Shares PV knowledge and experience with the organisation's personnel.
- To provide support to the Commercial Project Support department.
- To provide general PV training for all company employees.
- Develops PV knowledge by participating in external trainings and by self-training.
- Maintains good relationships with sponsors, local Competent Authority and Ethics Committee.
- Any other assigned duties.
- Good planning, organization and problem solving abilities.
- Good communication and interpersonal skills.
- Good analytical and negotiation skills.
- Computer competency.
- Fluent in local office language and in English, both written and verbal.
- University/college degree (life science preferred).
- At least years of clinical research experience (minimum 1 year in pharmacovigilance).
- Very good knowledge of GVP, GCP, local regulatory requirements, ICH Guidelines, European Directives.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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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