Medical Director, Device Safety Specialist
1 month ago
Company DescriptionJob Description
The Medical Director, Device Safety position plays a crucial role in ensuring the safety of pharmaceutical and biotechnology products. As a key member of the AbbVie team, this individual will be responsible for supporting the Product Safety Leads (PST) and potentially leading one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head.
The ideal candidate will have a strong background in pharmacology, chemistry, and non-clinical toxicology, with experience in conducting safety surveillance and authoring key pharmacovigilance documents. They will also possess excellent analytical and communication skills, with the ability to effectively write, review, and provide input on technical documents.
Responsibilities:
Key Responsibilities:
- Conduct safety surveillance for pharmaceutical and biotechnology products
- Author key pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans
- Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
- Lead the strategy for periodic reports (PSURs, PADERs, etc.)
- Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing
- Lead and implement risk management strategy for assigned products
Qualifications:
- MD/DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD/DO but not required
- 2-4 years of Pharmacovigilance experience in the pharmaceutical industry
- Experience in analyzing and guiding analysis of clinical data and epidemiological information
- Excellent communication and presentation skills
- Ability to effectively write, review, and provide input on technical documents
- Self-starting and can work independently
- Work collaboratively and lead cross-functional teams
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