Description
We are currently working with a world leader in research based in Pharmaceuticals who are looking to bring on a Drug Safety Manager on a 11 Month contract in May. In your role as a Drug Safety Manager you will be responsible for the following duties.Key Role Activities
- Safety Management and Reporting Act on behalf of the LSO in periods of their absence Supervise the collection,
- review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study reports, local literature, and all other potential sources
- Conduct initial quality review and assessment of local individual cases
- Write, review, validate and implement the (local) operating procedures/guidelines and verify adherence Manage and maintain active involvement in day-to-day AE reporting
- Co-ordinate the follow-up of missing information in safety cases and undertake site visits for follow-up of local cases of special interest
- Provide local data as required to support the preparation of Safety Summary reports (PSUR, DSUR, etc) Where applicable,
- support the Qualified Person (QP) for PV to provide safety-related regulatory communication (e.g. response to request for information from Local HA)
- Implement compliance standards and facilitate the collection of compliance metrics as required Give training on drug safety reporting of LOC personnel and maintain awareness of drug safety reporting in general
Essential Technical Knowledge, Skills and experience
- Proven ability to organise workflow activities and manage multiple critical issues
- Awareness of and familiarity with industry principles of pharmacovigilance, drug development and pharmacology Sound knowledge of Global and Local SOPs
- Sound knowledge of GMS database systems
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers
- Ability to establish and maintain open relationships within the organisation and with authorities Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety
Experience
Demonstrated pharmaceutical industry experience including solid experience in a PV responsibility role.
Qualifications
Life science degree or nursing qualification
For more information and the full Job Spec please contact Jamie on .
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Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales