UK - Drug Safety Associate - Senior
ProClinical is pleased to announce that one of the world's most renowned pharmaceutical companies is seeking a Drug Safety Associate to join their family. This top 10 company, which prides itself on its work across a range of industries from medical devices to pharmaceutical and consumer goods, is looking for an exceptional individual to join their team in the UK. The incumbent will join this team on a contract basis.
The Drug Safety Associate (DSA) will be responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices, and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.
- Completing full case information on the database, including quality review to ensure accuracy and completeness.
- Prioritising incoming cases for an optimal daily workflow management.
- Completing remain case data entries (including narrative or auto-narrative), manual coding, label, and approval.
- Preparing SUA summaries and analyses of similar events.
- Performing quality reviews of ICSR which includes reviewing source documents and ensuring that the case is accurate and that any applicable corrections to the case are incorporated.
- Liaising with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing.
- Completing all assigned training relating to relevant PV Agreements for assigned products.
- Participating in designated activities to support the revision/creation of case processing procedural documents.
- Participating in assigned projects, including inspection/audit readiness activities.
- Participating in inspections and audits as identified, including interviews and providing requested data.
- Participating in local or global project teams, including on-time delivery of assigned responsibilities.
- Mentoring other DSAs or staff as identified.
- Maintaining compliance with company guidelines and HR Policy Key attributes.
- Applying knowledge within single case processing of GMSO processes and guidelines, regulations and regulatory guidelines, contractual agreements, product-specific information, and database systems functionality.
- Communicating questions clearly and concisely to the appropriate audience, providing possible solutions where appropriate.
- Providing expertise in operation activities, including case processing, or other functional expertise.
Skills and Requirements:
- A Health/Biomedical Degree (BS, PhD, or other related scientific degree/qualification).
- A Certification/Licensure proving that the incumbent is a registered Nurse or Pharmacists.
- At least 5 years of experience in a pharmaceutical safety-related role in Pharma.
- A strong knowledge of pharmacovigilance.
- A strong knowledge of safety reporting and regulatory compliance, along with experience in international safety reporting/regulations.
- A thorough understanding of medical terminology and an ability to summarise medical information.
- An ability to follow guidelines and procedural documents (experience of working with SOPs, etc, preferred).
- Proficiency with computer software, such as MS Office and Visio.
- A detail and quality-oriented mindset, with a strong focus on decision making and problem solving.
- An ability to prioritise, plan, and organise work assignments, and to work under strict timelines.
- Excellent interpersonal skills, including communication, collaboration, and persuasion.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 319 3031 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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