Roles and Responsibilities:
- Work under the supervision of the Post Market Surveillance and Trending Lead to support safety vigilance for combination products and medical devices.
- Review regulatory updates from GPS PV Intelligence and evaluate their impact on Combination Product Safety (CPS).
- Perform literature searches and review findings related to applicable medical devices.
- Extract and analyze adverse event (AE) data from relevant databases to assess changes in post-product risk values.
- Pull and analyze external safety data from FDA MAUDE and FAERS databases.
- Evaluate correlations between product complaints (PC) and adverse events (AE) identified during monthly holistic reviews to assess potential patient and user safety risks.
- Reconcile lot-level AE excursions with PC excursions to support detailed trending analysis.
- Support post-marketing surveillance activities by collecting and analyzing safety data for combination products and medical devices.
- Prepare and provide metrics for governance forums and assist with audits and inspections as necessary.
Required Knowledge and Skills:
- Experience in safety within the biotech or pharmaceutical industry.
- Strong knowledge of complaint management and complaint trending within development, manufacturing, or post-market settings.
- Understanding of product complaint and adverse event intake and processing workflows.
- Ability to extract and analyze complaint and adverse event data on request.
- Familiarity with medical devices and combination products, including applicable global safety monitoring regulations and standards.
- In-depth knowledge of post-market safety reporting regulations for combination products and medical devices.
- Proficiency in data querying and visualization using Tableau, Power BI, or Python.
- Excellent interpersonal, teamwork, and communication skills.
- Strong scientific thinking, problem-solving skills, and attention to detail.
- Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
Preferred Knowledge and Skills:
- Advanced knowledge of combination products and medical devices regulatory environment.
- Strong data analysis skills and ability to generate actionable insights.
- Ability to work effectively within a matrix organizational structure.
- Good prioritization and time management skills.
Basic Qualifications:
- Doctorate degree with 8+ years of experience in post-market surveillance and data analysis; OR
- Master's or Bachelor's degree with 9+ years of experience in post-market surveillance and data analysis.
