Job Description
(Target PR: 35-40/hr)
Drug Safety Associate
Responsibilities
- Ensure timely and accurate processing of adverse event reports in accordance with company policies and regulatory requirements
- Conduct thorough investigations and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams
- Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders
- Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions
- Develop and maintain strong relationships with external partners, such as regulatory agencies and contract research organizations
- Assist with the development and implementation of pharmacovigilance processes and procedures
- Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance
- Participate in cross-functional meetings and contribute to the development of risk management plans for products
- Support the preparation and submission of regulatory reports and responses to safety-related inquiries
- Collaborate with other departments, such as Clinical Development and Medical Affairs, to ensure the safety of products throughout their lifecycle
- Maintain accurate and up-to-date documentation of all pharmacovigilance activities
- Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
- Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work
- Participates in project teams, and where required provides training and support to team members in respect of safety reporting
Qualifications
- Education – bachelor’s degree or equivalent professional experience
- Previous experience of 2+ years of Pharmacovigilance / Drug Safety in a CRO or Pharma, Biotech environment.
- Preferably, experience of safety report distribution and submission, as well as healthcare administrative
- Training – Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines
- Exceptional attention to detail with a focus on accuracy and meticulous
- Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
- In-depth understanding of global and local pharmacovigilance (PV) regulations
- Understanding of medical terminology and familiarity with coding dictionaries g
- Experience with ArisG or a similar Safety Database a plus.
- Strong project management, interpersonal, verbal and written communication
Job Tags
Remote job, Contract work, Local area,