Are you a healthcare professional with a passion for patient safety and pharmacovigilance? ProductLife Group is hiring a Patient Safety Associate to join their dynamic team. This is a remote, full-time position based in India, offering an excellent opportunity to work in a highly regulated industry and contribute to global patient safety initiatives.
About ProductLife Group
ProductLife Group is a leading global provider of regulatory, pharmacovigilance, and quality compliance services for the pharmaceutical, biotechnology, and medical device industries. With a strong focus on innovation and compliance, the company supports clients in ensuring the safety and efficacy of their products.
Job Overview
As a Patient Safety Associate, you will play a critical role in managing pharmacovigilance and safety-related projects. Your responsibilities will include processing safety information, evaluating adverse events, and ensuring compliance with regulatory requirements. This role is ideal for someone with a background in health sciences and a keen eye for detail.
Key Responsibilities
- Assist in the day-to-day delivery of pharmacovigilance and safety-related projects.
- Process and evaluate adverse events and product complaints in compliance with client procedures.
- Ensure accurate reporting of safety data according to SOPs and regulatory guidelines.
- Maintain the integrity of safety data in GxP databases and paper-based systems.
- Prepare project reports and track key performance indicators (KPIs).
- Participate in internal and external audits as required.
- Act as a subject matter expert and provide training to team members.
- Contribute to improving business processes and ensuring regulatory compliance.
Qualifications and Skills
- A degree in Health Sciences or a related field.
- Minimum of 12 months of experience in drug safety or a similar role within the pharmaceutical or medical device industry.
- Strong knowledge of regulatory requirements for adverse event reporting in Australia, New Zealand, EU, and APAC regions.
- Excellent communication, organizational, and problem-solving skills.
- High attention to detail and proficiency in safety databases.
- Experience in SOP writing and document management is a plus.
Why Join ProductLife Group?
- Remote Work: Enjoy the flexibility of working from home.
- Career Growth: Opportunities for professional development and mentorship.
- Global Impact: Contribute to projects that ensure the safety of pharmaceutical and medical products worldwide.
- Collaborative Environment: Work with a team of experts in pharmacovigilance and regulatory compliance.
