What are the responsibilities and job description for the Associate Director, Pharmacovigilance position at MMS?
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Responsibilities:
Responsibilities:
- Manages large, potentially technically diverse, teams of managers and/or senior professionals responsible for Drug Safety and PV service
- Oversees clinical trial and post-marketing activities, signal management, literature review, and ad hoc regulatory responses for Sponsors
- Provides scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, safety, and benefit-risk evaluations for Sponsors
- Strategically reviews clinical safety data, and through comprehensive analysis, to provide and provide to succinct assessments and communicate these effectively in verbal and written formats
- Leads the signal management process (signal detection, tracking, review meetings) for assigned product(s) and evaluates safety data as part of ongoing pharmacovigilance activities
- Supports safety related activities for global clinical trials, including but not limited to review of protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure, and clinical study report
- Manages literature review for safety information
- Supports medical monitoring activities
- Leads product safety surveillance activities for Sponsors during all phases of the product lifecycle (includes both investigational and marketed products)
- Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) and associated internal documents
- Medical/clinical professional degree (MD or equivalent - PharmD, RPh, RN degree) strongly preferred
- 7 years of experience in drug safety serving in a PV Scientist or similar role in a CRO/ Pharma/ Biotech environment
- Demonstrates managerial skill and experience
- Good communication skills and willingness to work with others to clearly understand needs and solve problems
- Good organizational and communication skills
- Ability to anticipate and effectively resolve potential problems with client demands
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