Planet Pharma
Senior Manager, Global Patient Safety Operations
Planet Pharma, Redwood City, California, United States, 94061
Senior Manager, Global Patient Safety Operations
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Senior Manager, Global Patient Safety Operations
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Planet Pharma Senior Manager, Global Patient Safety Operations
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Senior Manager, Global Patient Safety Operations
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Planet Pharma Job Description
Senior Manager, Global Patient Safety Operations Job Description
Senior Manager, Global Patient Safety Operations
The Opportunity
This position will be responsible for managing, developing, and overseeing Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.
Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures. Represent Global Patient Safety in different cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals. Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies. Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner. Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements. Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs. Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports. Support the execution and maintenance Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners. Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities. Support Global Patient Safety team in other PV activities appropriate to experience and expertise. May oversee or be responsible for one or more junior team member(s).
Required Skills, Experience And Education
Bachelor’s degree in a healthcare field. Minimum of 5 years of relevant experience in pharmacovigilance operational activities. Hands-on experience working with CROs/vendors and management of external resources. Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials. Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables. Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives. Ability to persuade others in sensitive/complex situations while maintaining relationships An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment. Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors. Exercise discretion regarding highly confidential internal and external communications.
Preferred Skills
Master’s Degree or higher in a healthcare field. 7+ years of relevant experience in pharmacovigilance operational activities. Experience working with investigator-sponsored trials, extended use programs, and business partnerships.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Safety Manager” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join to apply for the
Senior Manager, Global Patient Safety Operations
role at
Planet Pharma Senior Manager, Global Patient Safety Operations
1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager, Global Patient Safety Operations
role at
Planet Pharma Job Description
Senior Manager, Global Patient Safety Operations Job Description
Senior Manager, Global Patient Safety Operations
The Opportunity
This position will be responsible for managing, developing, and overseeing Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.
Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures. Represent Global Patient Safety in different cross-functional team meetings. Collaborate with other functional groups to achieve clinical program goals. Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies. Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner. Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, investigators to ensure compliance with global regulatory requirements. Ensure timely and accurate set up of global safety reporting and safety database in assigned clinical programs. Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports. Support the execution and maintenance Safety Data Exchange Agreements/Pharmacovigilance Agreements with business partners. Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities. Support Global Patient Safety team in other PV activities appropriate to experience and expertise. May oversee or be responsible for one or more junior team member(s).
Required Skills, Experience And Education
Bachelor’s degree in a healthcare field. Minimum of 5 years of relevant experience in pharmacovigilance operational activities. Hands-on experience working with CROs/vendors and management of external resources. Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials. Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables. Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives. Ability to persuade others in sensitive/complex situations while maintaining relationships An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment. Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors. Exercise discretion regarding highly confidential internal and external communications.
Preferred Skills
Master’s Degree or higher in a healthcare field. 7+ years of relevant experience in pharmacovigilance operational activities. Experience working with investigator-sponsored trials, extended use programs, and business partnerships.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Industries Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Sign in to set job alerts for “Safety Manager” roles.
Manager of Industry Safety and Fire Prevention
South San Francisco, CA $84,800.00-$155,500.00 2 weeks ago Senior Workplace Environmental Health and Safety Specialist
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Oakland, CA $144,000.00-$244,000.00 1 week ago Safety, Security, and Facilities Manager - Onsite
Oakland, CA $100,000.00-$150,000.00 2 months ago Milpitas, CA $141,568.00-$208,188.00 2 weeks ago Airfield Safety Officer (9213) - Airside Operations - SFO
San Francisco, CA $114,114.00-$138,684.00 3 days ago Alameda, CA $172,000.00-$245,000.00 2 weeks ago Oakland, CA $120,000.00-$200,000.00 5 days ago Santa Clara, CA $160,000.00-$200,000.00 5 days ago Milpitas, CA $141,568.00-$208,188.00 3 weeks ago Fremont, CA $130,000.00-$150,000.00 1 week ago Director, Global Health and Safety (Remote)
Sunnyvale, CA $150,000.00-$240,000.00 2 weeks ago Mountain View, CA $120,000.00-$140,000.00 1 week ago Regional Environmental Health and Safety Manager
Senior Manager, Global Patient Safety Operations
Regional Safety & Security Manager- North America
Environmental Health & Safety Officer (EHS Officer)
San Francisco Bay Area $35.00-$50.00 3 weeks ago San Francisco, CA $150,000.00-$160,000.00 18 hours ago Senior Manager, Global Patient Safety Operations
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San Mateo County, CA $70.00-$80.00 1 week ago Environmental Health & Safety (EHS) Manager - USDS
San Jose, CA $108,800.00-$195,912.00 3 weeks ago Menlo Park, CA $100,000.00-$145,000.00 2 weeks ago Sunnyvale, CA $110,000.00-$140,000.00 2 weeks ago Senior Manager, Safety & Security, (Stadium or Non Competition Sites) - San Francisco/Bay Area, CA, FIFA World Cup 2026
Senior Manager, Global Patient Safety Operations
San Mateo County, CA $70.00-$80.00 3 days ago Senior Manager, Global Patient Safety Operations
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr