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Medical Safety Officer Usa
Company | Philip Morris International |
Address | Washington, DC, United States |
Employment type | OTHER |
Salary | |
Category | Tobacco Manufacturing,Manufacturing |
Expires | 2023-09-08 |
Posted at | 8 months ago |
Medical Safety Officer USA – Washington, D.C.
- Ensure compliance with regulatory requirements, including FDA and other relevant international standards (e.g. GVP)
- Perform medical assessment of serious adverse events originating from USA in post market setting and occurring in clinical trials
- Act in compliance with applicable internal standards/procedures
- Support the Head of Medical Safety Office with establishment and implementation of PMI medical safety related policies, procedures and programs related to assessment studies in humans for RRPs and post-market setting
- Provide review of Safety Update Reports and other safety medical documents
- Ensure that safety risks are assessed, and mitigation plans put in place for USA. Ensure that safety information is communicated effectively internally and externally, also to regulatory authorities and consumers with oversight from the Head of Medical Safety Office
- Provide guidance to USA safety scientists.
- Act as primary contact point for any safety related questions coming from local regulatory authority (e.g. FDA)
- Ensure safety training of applicable USA functions
- Provide oversight of the products safety and risk management of PMI RRPs in USA
- Lead the implementation of country specific safety surveillance plans including signal detection and risk management activities
- Collaborate with US cross-functional teams to ensure that safety-related issues are identified and led appropriately.
- Strong analytical and problem-solving skills
- Minimum 3 years’ experience in a leading pharmacovigilance/safety role in pharmaceutical, biotech or tobacco company
- Fluent in written and spoken English.
- Experience with signal detection and risk management activities is preferred
- Extensive knowledge of global pharmacovigilance/safety regulations, including FDA regulations and standards
- Medical Doctor
- Legally authorized to work in the U.S..
- Excellent communication and interpersonal skills, with ability to build effective relationships
- Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.
- Take pride in delivering our promise to society: a smoke-free future.
- Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore.
- Be part of an inclusive, diverse culture where everyone’s contribution is respected; Collaborate with some of the world’s best people and feel like you belong.
- We offer a competitive base salary, annual bonus (applicable based on level of position), great medical, dental and vision coverage, 401k with a generous company match, incredible wellness benefits, commuter benefits, pet insurance, generous PTO, and much more!
- We have implemented Smart Work, a hybrid model of working that promotes flexibility in the workplace.
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