Pharmacovigilance Officer X2

As a PV Officer you will work within the Pharmacovigilance Operations team and will be dedicated to one or more of our pharmaceutical clients with a truly global presence supporting the collation, processing and analysis of safety information on behalf of a Client’s product; this unique industry-changing relationship redefines collaboration.

This role requires you to be a passionate pharmacovigilance professional, who is a dedicated and enthusiastic team player, that wants to work with a new business that strives to gain and maintain an exceptional reputation as a PV Service Provider that is knowledgeable, cares and produces high quality work.

**Key Responsibilities**:

- Perform quality control of other PV Operations activities
- Investigating cases of non-compliance of SAEs/ICSRs and supporting development of non-conformances and corrective and preventative actions.
- Provide oversight and support to Operational Team for processing safety information and forwarding to the client/third party vendor within stipulated timelines.
- Maintain oversight of reconciliation activities with internal departments/client/third parties
- Support and manage the PV mailbox
- Investigating late adverse event and deviations, followed by developing and implementing appropriate corrective and preventative actions in a timely manner
- Responsible for collection of Key Performance Indicators (KPI) and providing input in the monthly compliance report.
- Improve and enhance internal processes to increase efficiency
- Actively participate in preparation of client/third party/vendor audits and provide back-up support with PV Operational Management activities, as and when required
- Develop PV medical training presentations. deliver training and mentor PV staff as well as support with relevant SOP authoring. Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system and actively participating in PV inspections or audits
- Literature search string formulation and sensitivity testing
- Oversee Case regulatory reporting;
- Provide PV Operations input into preparation and set-up of new client projects/products, ensuring procedures and SMPs/COGs are accurate and effective to ensure compliance.
- Assist with case processing workflow when needed to ensure due dates are met.
- Ensure all regulatory reporting is performed in full compliance with regulations and applicable ICH/GCP guidelines
- Assist with resolution of any identified non-conformances
- Ensure monitoring of compliance metrics performed as required and timelines are being met for expedited reporting.
- Communicating with Clients and/Partners regarding the evaluation and processing of ICSRs
- Expedited Reporting activities involving Work Instruction Updates, System Reporting Rules, Regulatory Intelligence, Clinical Reporting Instructions Updates.
- Participation in Client audits and inspections
- Support Safety Evaluation and Risk Management (SERM) team with aggregate PV data analysis for signal detection/aggregate reporting purposes
- Act as a Local Qualified Person for Pharmacovigilance (LQPPV), if contracts with clients require this activity and if they are resident in a relevant country
- Provide input and support into periodic client activity reports
- Support the collation and dissemination of quality and compliance metrics for pharmacovigilance and medical information activities
- May be required to line manage PV Associates/Senior PV Associates.

**Requirements**:

- Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree
- Proven and demonstrable experience in PV
- Evidence of being able to build relationships with key internal and external customers and demonstrate customer focus
- Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities
- Excellent organizational and prioritization skills and strong analytical / problem solving skills
- Excellent oral and written communication skills
- Ability to build relationships with key internal and external customers
- Excellent attention to detail and ability to work under pressure
- Extensive knowledge of MS Office Applications and systems
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
- Proven ability to work collaboratively within a matrix and/or cross-functional environment
- Self-motivated and organised, with the ability to work unsupervised for periods of time
- Excellent analytical thinking, with the ability to evaluate and present complex safety data

**Benefits**
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme &