Product Surveillance Reporting Specialist
4 weeks ago
SRG is partnering with a leading pharmaceutical organisation to find a skilled Product Surveillance Reporting Analyst to join their team in Marlow.
Purpose of the Role
The Reporting Specialist will be responsible for executing all reporting activities, collaborating with internal and external stakeholders. This includes partnering with pharmacovigilance, regulatory affairs, in-country teams, and device QA to ensure accurate and timely reporting of complaints.
Key Responsibilities:
- Decision maker for all reportability decisions
- Lead for all vigilance reporting, including local and global submissions
- Collaborate with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalate requests as necessary
- Ensure relevant stakeholders have visibility into the reporting process
- Manage regular reporting needs and external requests
- Manage the timeline for end-to-end reporting
- Own translation services for reporting
Requirements:
- Bachelor's Degree in a life science, pharmacy, nursing, or other scientific field
- 5+ years of experience in a cGMP related industry or clinical setting
- Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products
- Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211)
- Ability to prioritise multiple projects to ensure compliance with regulations and standard operating procedures
- Solid written and verbal communication and organisational skills
- Knowledge and application of computer systems for word processing and complaint management
- Ability to work with cross-functional teams and interact effectively with peers, management, and customers
About SRG
SRG is a leading recruitment agency specialising in the life sciences industry. We work closely with top pharmaceutical companies to find talented professionals like you.
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