Drug Safety Associate

3 days ago

Sydney, Australia Grand Pacific CRO Full time

**About Us**:
The Grand Pacific CRO team has over 25 years’ experience in conducting clinical trials in the Asia Pacific region, including Australia, New Zealand and South Africa. We have continued as a leader in the industry and have expanded services to include central laboratory, site management and image reading services. We pride ourselves on meeting customers where they are and providing exactly what they need to move their products forward.

**Job summary**

The Drug Safety Associate is responsible for delivering day to day operational activities across medicines and medical devices for local and global projects.

**Responsibilities**
- Participate in day-to-day operational activities including receiving, review and triaging of safety information from Investigator sites and adverse experiences from post marketing sources
- Participate in data entry, medical coding in safety database, reconciliation, query resolution, narrative preparation, and submissions.
- Follow-up activities on case reports are performed as required and in accordance with relevant procedures and within business timelines
- Support the clinical project team in the preparation of all customized and other regulatory safety reports including Periodic Reports, (DSURs, PBRERs, PSURs), cumulative SAE reports and safety database reports
- Support in the development and review of safety related documents including safety data collection forms & templates, case report forms, and clinical study reports
- Assist the PV manager to develop and implement plans to drive growth in this business area.
- Participate in delivering PV training for Grand Pacific CRO staff, Clients and 3rd party vendors
- Perform other safety/PV operations-related tasks as necessary

Delivery
- Participate and ensure that the PV activities are delivered according to best Good Pharmacovigilance Practice (GPV) and in accordance with regulatory and contractual agreements
- Technical administrative support relating to the maintenance of internal systems for PV activities

**Qualifications**:

- Degree or equivalent combination of education, training and relevant industry experience

Technical knowledge, skills and other requirements
- Strong time management skills and ability to multitask to maintain demanding timelines.
- Self-starter with ability to adapt and be flexible to changing priorities
- Attention to detail and ability to work simultaneously on multiple priorities
- Excellent communication, organizational and interpersonal skills
- Must have excellent oral, written, presentation and computer skills
- Collaborative and constructive team-member
- Able to communicate technical concepts to non-technical cross-functional team members

Work experience
- 3 - 4 years PV/Drug Safety experience within the pharmaceutical industry/CRO environment
- Post Marketing and Clinical trial experience required
- Safety Database experience (e.g., Argus)
- Knowledge in MedDRA and WHO drug coding.
- Knowledge of US, EU and other international PV regulations for safety reporting and the systems needed to ensure compliance.
- Awareness and understanding of industry regulations and guidelines. (eg. GCP ICH, 21 CFR Part 11, HIPPA)

Job measurement
- Successful participation in case management and other PV activities, as required for the role.
- Effective participation in study related activities and set-up.

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