Are you looking for a new role as a Drug Safety Associate? An outstanding opportunity has arisen for a Drug Safety Associate of the highest calibre to join one of the world's largest and leading pharmaceutical companies.
The Drug Safety Associate 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.
- Free on site gym
- Free parking
- Weekly pay
- Holiday pay
- Pension plan
- On site restaurant
- Triage of incoming cases to prioritize for daily workflow management
- Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
- Preparation of SUA summary: Analysis of Similar Events
- Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
- Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
- Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
- Processes & procedures: awareness of and input to company procedures and guidance
- Completion of all assigned training on company and GMSO procedural documents relating to case processing
- Completion of training relating to relevant PV Agreements for assigned products
- Participate in designated activities to support revision/creation of case processing procedural documents
- Participation in local or global project teams, including on-time delivery of assigned responsibilities
- Participation in inspections and audits as identified, including interviews and provision of requested data
- Mentoring of other DSAs or staff, as identified
- Maintains compliance with company guidelines and HR Policies
Qualifications and experience:
- Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
- Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
- Licensed Practical Nurse with Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by minimum 5 years experience in pharmaceutical safety-related role
- Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas
- Case processing experience is desired
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
- Understanding of medical terminology and ability to summarize medical information
- Ability to follow guidelines and procedural documents (experience of working with SOPs etc preferred)
- Oriented to quality, attention to detail and accuracy
- Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
- Ability to work both independently and in collaboration with others
- Proactive approach/uses own initiative appropriately
- Decision-making and problem-solving skills
- Flexibility and adaptability
- Positive attitude
- Good verbal and written communication skills
- Good computer skills (Word, email) and familiarity with safety systems
- Knowledge or experience with Excel, PowerPoint, Visio preferred
If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.