Senior Pharmacovigilance (PV) Scientist

Gaithersburg, MD 20878

Posted: 11/15/2018 Industry: Other Area(s) Job Number: 32523

Senior Pharmacovigilance (PV) Scientist

The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses. Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.  Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.  Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.  Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects. Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.  

Required:

Pharmacovigilance experience, Risk Management, safety surveillance, time management and organizational skills.

• A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience

• Fluent in written and verbal English

• Advanced knowledge of PV regulations

• MD/MSc/PhD in scientific discipline, preferred

• Intermediate understanding of epidemiology, preferred by example through participating in recruitment activities, training colleagues, leading safety team meetings, etc.

 
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