Planet Pharma
Join to apply for the
Associate Director Safety Science
role at
Planet Pharma 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director Safety Science
role at
Planet Pharma Get AI-powered advice on this job and more exclusive features. Description
Job Description
The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals.
Scope
Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting. Assist in follow-up of important ICSRs to ensure relevant information is sought. Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals. Participate in the development development of safety surveillance and risk management plans for drug development programs. Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report). Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed. Participate in the preparation and revision of company product labeling and RMP as appropriate. Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents. Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
Deliverable (please Have Experience With)
ICSR reviews in Argus safety database. Completed quarterly signal evaluation forms. Completed signal issue work-ups. Completed aggregate reports. Risk Management Plans. Slide decks for Safety Management Team/Product Safety Committee meetings.
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 Director roles.
Alameda, CA $172,000.00-$245,000.00 3 weeks ago Director (JC-482828) - Rail Safety Division
San Francisco, CA $175,000.00-$200,000.00 3 days ago Associate Director, Food Safety & Quality Assurance
Alameda, CA $160,000.00-$195,000.00 1 week ago South San Francisco, CA $140,000.00-$180,000.00 1 month ago San Francisco, CA $124,400.00-$291,600.00 8 months ago South San Francisco, CA $235,144.00-$290,472.00 2 days ago Safety Manager (or Director)- Heavy Civil
North Richmond, CA $130,000.00-$160,000.00 18 hours ago Global Director of Safety, Health, and Environment (HSE)
Alameda, CA $180,000.00-$240,000.00 1 month ago Safety Manager (or Director)- Heavy Civil
San Rafael, CA $130,000.00-$160,000.00 4 days ago San Rafael, CA $140,000.00-$180,000.00 18 hours ago Campus Fire Marshal, Director of Fire Prevention (0491U) #78833
Director, Clinical Quality & Patient Safety
Senior Director of Quality and Patient Safety
San Francisco, CA $144,200.00-$350,000.00 3 months ago Executive Medical Director, Head of Safety Science
Head of Waymo Training and Documentation
San Francisco, CA $226,000.00-$286,000.00 3 weeks ago South San Francisco, CA $235,144.00-$290,472.00 3 weeks ago Interim Director of Pharmacy (DOP) Bay Area, CA
Senior Medical Director, Patient Safety & Pharmacovigilance
South San Francisco, CA $287,292.00-$354,891.00 2 days ago Senior Director of Engineering, Identity - Safety & Civility
San Mateo, CA $500,210.00-$546,060.00 1 week ago Director - Infection Prevention & Control
Oakland, CA $135,200.00-$140,000.00 2 weeks ago South San Francisco, CA $130,000.00-$135,000.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Associate Director Safety Science
role at
Planet Pharma 1 day ago Be among the first 25 applicants Join to apply for the
Associate Director Safety Science
role at
Planet Pharma Get AI-powered advice on this job and more exclusive features. Description
Job Description
The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals.
Scope
Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving company products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting. Assist in follow-up of important ICSRs to ensure relevant information is sought. Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals. Participate in the development development of safety surveillance and risk management plans for drug development programs. Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR (PBRER format), US PADER, Annual Safety Report, DSUR, IND Annual Report). Serve on Safety Management Team and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed. Participate in the preparation and revision of company product labeling and RMP as appropriate. Assist with preparation and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other safety documents. Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
Deliverable (please Have Experience With)
ICSR reviews in Argus safety database. Completed quarterly signal evaluation forms. Completed signal issue work-ups. Completed aggregate reports. Risk Management Plans. Slide decks for Safety Management Team/Product Safety Committee meetings.
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 Director roles.
Alameda, CA $172,000.00-$245,000.00 3 weeks ago Director (JC-482828) - Rail Safety Division
San Francisco, CA $175,000.00-$200,000.00 3 days ago Associate Director, Food Safety & Quality Assurance
Alameda, CA $160,000.00-$195,000.00 1 week ago South San Francisco, CA $140,000.00-$180,000.00 1 month ago San Francisco, CA $124,400.00-$291,600.00 8 months ago South San Francisco, CA $235,144.00-$290,472.00 2 days ago Safety Manager (or Director)- Heavy Civil
North Richmond, CA $130,000.00-$160,000.00 18 hours ago Global Director of Safety, Health, and Environment (HSE)
Alameda, CA $180,000.00-$240,000.00 1 month ago Safety Manager (or Director)- Heavy Civil
San Rafael, CA $130,000.00-$160,000.00 4 days ago San Rafael, CA $140,000.00-$180,000.00 18 hours ago Campus Fire Marshal, Director of Fire Prevention (0491U) #78833
Director, Clinical Quality & Patient Safety
Senior Director of Quality and Patient Safety
San Francisco, CA $144,200.00-$350,000.00 3 months ago Executive Medical Director, Head of Safety Science
Head of Waymo Training and Documentation
San Francisco, CA $226,000.00-$286,000.00 3 weeks ago South San Francisco, CA $235,144.00-$290,472.00 3 weeks ago Interim Director of Pharmacy (DOP) Bay Area, CA
Senior Medical Director, Patient Safety & Pharmacovigilance
South San Francisco, CA $287,292.00-$354,891.00 2 days ago Senior Director of Engineering, Identity - Safety & Civility
San Mateo, CA $500,210.00-$546,060.00 1 week ago Director - Infection Prevention & Control
Oakland, CA $135,200.00-$140,000.00 2 weeks ago South San Francisco, CA $130,000.00-$135,000.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr