Medical Safety Expert Job

MEDICAL SAFETY EXPERT needed for a CONTRACT opportunity with Yoh's client located in Parsippany, NJ.

WHAT YOU'LL BE DOING:

- Provide guidance on medical review and assessment of Individual Case Safety Reports Provide input and own medical content of safety aggregate reports (eg PSURs, PADERs, safety Risk Management Plans)
- Provide input on post-marketing experience for registration/switch/renewal dossiers and ensure support to Health Authority queries
- Provide expert medical safety input to company core safety information and clinical development programs (eg Clinical Trial Protocol, Clinical Trial Report, Post-Authorization Safety Study)
- Be responsible for overall medical evaluation of safety signals for assigned products, and involvement of cross-functional expertise (preclinical, clinical, post-marketing, literature), when relevant.
- Ensure appropriate review of safety topics at the Safety Review Committee.
- Be responsible for development and timely update of key internal safety documents (eg when new significant safety information arises).
- Ensure data consistency among all safety and other project-related documents.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor of Science in Pharmacy/Bachelor of Science in Nursing/PharmD/PhD in healthcare field or Medical Degree (MBBS or MD) required
- Four (4) years of progressive experience in pharmaceutical industry with a minimum of two (2) years in Drug Safety OTC experience preferred
- Experience leading projects in a global pharmaceutical setting preferred
- Expertise in preparation of safety assessments and regulatory reports/submissions involving safety information, including CTD/NDA submission documents, RMPs, etc.
- Strong knowledge of varying types of content within aggregate safety reports, including PSURs, DSURs. etc.
- Ability to work independently, under pressure, demonstrating initiative and flexibility

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: CLINICAL

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