Pharmacovigilance Specialist, Drug Safety & Medical Devices
Overview
You will own adverse event processing and regulatory reporting for all Merz Aesthetics products, including medical devices, cosmetics, and OTCs. You will ensure FDA and EU compliance for both marketed and investigational products, handling SAEs, AEIs, and pregnancy reports. You will work with clinical teams to develop safety sections for protocols and Investigator Brochures. You will use validated safety databases like Argus and ARISg to submit cases to worldwide agencies. This role offers a hybrid schedule with 3 days onsite and 2 days remote.
What You'll Do10
- 1Process adverse event reports from all sources for medical devices, cosmetics, and OTCs, including medical assessment and narrative writing.
- 2Enter reports into the safety database, write comprehensive narratives, and conduct follow-up for all product types.
- 3Support clinical study SAE processing by developing safety sections for protocols and Investigator Brochures.
- 4Write Safety Management Plans and participate in end-of-study activities like SAE reconciliation.
- 5Submit individual AE and SAE reports to regulatory agencies, partners, and affiliates within required timelines.
- 6Evaluate individual case reports using medical knowledge and verify MedDRA and IMDRF coding.
- 7Perform periodic and ad-hoc literature reviews to identify reportable safety cases.
- 8Generate queries and reports from safety databases for internal and external requests.
- 9Train clinical investigators, sales reps, and staff on adverse event reporting obligations.
- 10Support audits and collaborate with Quality, Clinical, Regulatory, and Medical Affairs teams.
Requirements8
- 15+ years of experience in drug safety or medical device vigilance in an industry setting.
- 2Bachelor's degree in a science or healthcare-related field, or RN/PharmD.
- 3Strong knowledge of FDA and EU regulations for clinical safety and vigilance.
- 4Experience with validated safety databases like Argus, ARISg, or SIAB.
- 5Proficiency in MedDRA, WHODrug, and IMDRF coding.
- 6Experience with clinical trial SAE processing and regulatory submission timelines.
- 7Ability to work effectively in a collaborative team environment.
- 8Strong organizational, project management, and communication skills.
Salary Insight
$83 - $87k per year
Location
Required Skills
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