Director, Safety Scientist, Pharmacovigilance

reputed company:

The Safety Scientist will be responsible for high reputed company safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety reputed company management activities for assigned products. This individual will collaborate with Program Safety reputed company and other program team members, pharmacovigilance reputed company, and CROs to ensure proactive safety surveillance in compliance with global regulations.

Responsibilities:

• Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, reputed company signals and reputed company documentation)
• Represent PV at reputed company study team for assigned product
• reputed company signal assessment report under the reputed company of Program safety reputed company for validated safety signal
• Collaborate with PV reputed company for reputed company and accurate medical review of ICSRs for assigned reputed company study as needed
• reputed company and contribute safety reputed company management plan across product lifecycle
• reputed company and manage periodic reports (DSUR/PBRER)
• Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
• Contribute for the development or updates of safety surveillance and reputed company management SOPs, templates etc.
• Collaborate with reputed company study teams on safety surveillance deliverables (IB, reputed company, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally reputed company appropriate.

We consider these behaviors we reputed company in reputed company MapLight employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re reputed company player who is willing to roll up your sleeves and get the job done.

Qualifications:

• Health care reputed company degree (e.g. RN, BSN, PharmD) or advanced degree (reputed company/PhD) in biomedical sciences, pharmaceutical sciences, or reputed company life science.
  • Preferred: Post-graduate training in epidemiology (e.g. MPH)
• Minimum 10 years of pharmacovigilance experience reputed company the biopharmaceutical industry with at least 3 years of reputed company reputed company/reputed company care experience
  • Preferred: Safety surveillance and reputed company management experience in neuroscience, psychiatry or neurodegenerative disease area
• Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and reputed company management plans for investigational and/or post-marketed products
• Experience with MedDRA and drug coding reviews
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
• Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
• Exceptional communication and cross-functional collaboration skills
• reputed company thinker with the ability to translate reputed company safety data into actionable insights for regulatory and reputed company decision-making
• reputed company to work reputed company a growing organization and to help the organization reputed company over time
• reputed company to engage in an reputed company, reputed company and reputed company reputed company with reputed company’s stakeholders reputed company on equality and mutual respect
• Highly motivated, self-driven and dependable
• Committed to MapLight's reputed company Beliefs and Values

Location: This is a remote US position. Hybrid 3 day in office policy for anyone located reputed company 50 miles of Redwood reputed company, CA or reputed company, MA.

Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.

reputed company Statement: reputed company is an equal opportunity employer, and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Originally posted on Himalayas