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1) Health and Safety (HSE) Coordinator – 7 month contract (Missouri) 990
2) Sr. Manager, Drug Safety – Full Time Position (San Francisco Bay Area) UT16L
3) Drug Safety Physician – Full Time Position (San Francisco Bay Area) TL16B
4) Clinical Safety Data Manager – Full Time Position (San Francisco Bay Area) V71LN
5) GCP Inspection Specialist – Full Time Position (San Francisco Bay Area) S62BG
6) Director Pharmacovigilance – Full Time Position (San Francisco Bay area) P54GT
1) Health and Safety (HSE) Coordinator – 7 month contract (Missouri) 990
DESCRIPTION:
- Knowledge of OSHA requirements, Dept. of natural resources, RCRA, regulations.
- Ability to develop SOP’s for related tasks.
- Industrial hygiene, ergonomics, noise monitoring experience.
- Manages CAPA for HSE tasks.
- Coordinates waste programs and provides oversight.
EXPERIENCE AND QUALIFICATIONS:
- Possess good written and oral communication skills
- Possess strong interpersonal skills
- Ability to write Standard Operating Procedures (SOP)
- Ability to read and interpret policies, programs and regulations
- Relies on minimal instructions and pre-established guidelines and timetables to perform the functions of the job
- Ability to work under pressure and with time constraints
- Computer abilities include Word, Excel, Adobe, PowerPoint, and Outlook
- Bachelor of Science degree preferred
- 2 – 3 years safety experience.
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) Sr. Manager, Drug Safety – Full Time Position (San Francisco Bay Area) UT16L
DESCRIPTION:
- Reviews and prioritizes information received on serious adverse events (SAEs) for all investigational products. Performs initial assessment of case using scientific and drug safety knowledge. Process SAEs from receipt to case closure in the ArisG database including query generation, and narrative and SAE writing. Ensures adverse event (AE) reports are submitted appropriately to regulatory authorities.
- Defining and applying a high standard of quality review to ensure sound medical safety data documentation.
- MedDRA coding of SAEs and AEs as reported in source documents of SAE reports, and development/revision of MedDRA Coding Conventions, ensuring consistent data categorization.
- Review of study protocols, case report forms, Investigator Brochures and participation on Investigational New Drug Annual Reports.
- Compilation/finalization of SAE Management Plan covering study-specific SAE workflow between Contract Research Organizations and the company.
- Develops, reviews and updates drug safety forms and templates and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form and case report form).
- Develops training material for Drug Safety Associates, non Drug Safety relevant personal, clinical site training.
- Secretary of the Data Safety Monitoring Committee held on the group products (safety data compilation, minutes).
- Identifies and pursues global and long-term goals for the department, in collaboration with department head and Medical Monitor, taking into account and providing support for the strategic goals of the business.
- Provides support and back up for Medical Monitor, Vice President of Clinical Research Operations, and Vice President of Clinical Development.
- Coordinates and prepares sections of relevant Periodic Safety Update Reports, other periodic safety reports and manages safety updates for labeling.
- Assessment of safety signals and trends, and to proactively manage any potential safety issues.
- Participates in strategic planning, workflow development, standard operating procedures updates, audits, data analysis and clinical team meetings.
- Trains appropriate cross functional personnel and external groups in drug safety principles and practices.
- Develops contacts across company, and uses those contacts to manage projects more effectively.
- Manages Drug Safety Group
EXPERIENCE AND QUALIFICATIONS:
- Must have excellent attention to detail, teamwork, and initiative.
- A proven track record in successful people management, with an extensive understanding of the different styles and approaches to be used in managing team members.
- Must be able to provide direction to a team. Must be able to interact with other departments within the company, and be proficient in written and verbal communication.
- Must have a highly developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations within drug safety.
- Previous experience and understanding of a drug safety database is required along with a proficiency in Microsoft Excel, Power Point, and Word.
- RN, Pharm.D., MD, or equivalent degree, preferably in a health science field, with a minimum of 3 years of clinical experience and a minimum 5 years of relevant drug safety experience in biotechnology/pharmaceutical industry.
- EudraVigilance certified.
- Oncology experienced essential.
To apply for a position send your resume to Jobs@JGBBioPharma.com
3) Drug Safety Physician – Full Time Position (San Francisco Bay Area) TL16B
DESCRIPTION:
- Drug Safety Physician will contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for the Company’s investigational products.
- Will be responsible for on-going safety surveillance and signal detection/analysis and will manage and provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety.
- In addition, together with other physicians in Clinical Development, will monitor designated clinical trials and provide out of hours coverage. The candidate will also chair the company’s Executive Safety Advisory Committee (ESAC).
Job Responsibilities:
- Manages the Safety Group
- Medical and scientific Pharmacovigilance review of: Literature Reports including epidemiological background research; Clinical Trial Reports; Study Protocols; Investigator Brochures, Clinical Trial (Serious) Adverse Event Reports; Post-marketing ADR reports; Case files, narratives, coding, causality and expectedness assessment
- Analysis of Adverse Event Reports during on-going surveillance and signal detection, including independent analysis of safety risks
- Writing of safety section, including benefit risk assessment, of PSURs, Clinical Expert Statements and other documents as required; general PSUR support
- Provide medical guidance to Safety Staff during the case processing cycle
- Review and sign off technical documents written by the company with respect to medically relevant matters with particular attention to those relating to drug safety
- Chairs the company’s Executive Safety Advisory Committee (ESAC)
- Attend and present material (such as therapeutic area training), as requested, at internal and external meetings (such as investigator meetings)
- Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs)
- Maintain up-to-date knowledge of projects by attending Professional Society Meetings
- Provide medical safety expertise and training to other personnel, as required
- Maintain a current medical license
- Keep current with professional and Pharmacovigilance regulations and knowledge
- Monitor designated clinical studies and provide out of hours coverage together with other physicians in Clinical Development
EXPERIENCE AND QUALIFICATIONS:
- The appointee will be a MD who is board certified in internal medicine, with an active US medical license.
- Clinical experience in oncology or hematology will be a plus.
- A total clinical research experience of approximately 8+ years, with at least 4+ of years in a biopharmaceutical organization with the primary responsibility for Drug Safety and Pharmacovigilance.
- The position reports directly to the Chief Medical Officer.
- Relocation assistance is available for this role.
To apply for a position send your resume to Jobs@JGBBioPharma.com
4) Clinical Safety Data Manager – Full Time Position (San Francisco Bay Area) V71LN
DESCRIPTION:
The Clinical Safety Manager is responsible for managing the efficient collection, processing, and review of safety data from clinical trials. This position serves as a technical resource in the conduct of Phase I to Phase III Clinical Trials.
- Directly manages staff and conducts recruitment and on-boarding ; Oversees the work of direct reports to ensure on-time, on-target and within-budget results
- Select and implement internal thesaurus management system and Select and oversee external thesaurus management vendor
- Ensure consistency of classification within a study and across studies for the same compound
- Set global classification conventions
- Author study specific thesaurus management plan with classification conventions; Perform thesaurus classification of adverse events to MedDRA
- Perform thesaurus classification of concomitant medications to WHO drug
- Create and maintain thesaurus management SOPs, work instructions and template; Perform SAE vs AE reconciliation
- Perform clinical data review consistency between medical history, adverse event and concomitant medication
- Perform clinical data review consistency between lab data and adverse event data
- Provide technical assistance to the CDM, clinical, safety, medical and biostatistics departments – Thesaurus, central lab, and local lab management
EXPERIENCE AND QUALIFICATIONS:
- Excellent oral and written communication skills.
- Understanding and familiarity of the drug development process.
- Knowledge of execution of Phase I-III Clinical Trials.
- Excellent knowledge of MedDRA and WHO drug coding dictionaries required
- Basic knowledge of SAS dataset structure required, working knowledge preferred.
- Excellent knowledge of local and central lab data required
- 8+ years clinical development experience required.
- 3 years management experience required.
- Working knowledge of paper based/ fax based and electronic data capture (EDC) processes and software.
- Working knowledge of adverse event and concomitant medication classification processes and software.
- Master’s Degree and 5+ years clinical development experience required; or
- Bachelor’s Degree and 10+ years clinical development experience required. or
- No degree and 15+ year clinical development experience required.
To apply for a position send your resume to Jobs@JGBBioPharma.com
5) GCP Inspection Specialist – Full Time Position (San Francisco Bay Area) S62BG
DESCRIPTION:
The Inspection Specialist supports our Company’s organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities. This position is in the Quality department.
Major Responsibilities and Accountabilities
- Coordinates scheduling and logistics for inspection related activities.
- Collaborates with other Pharma functional areas for activities related to inspection preparation. Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
- Participates in pre-inspection visits of investigator sites.
- Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection. Assumes a role as required by the scope and nature of the inspection.
- Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
- Assists in the preparation, conduct and management of mock inspections conducted of our Company’s functional areas.
- Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within our Company’s Pharma.
- Assists in preparing periodic summary reports and trend reports related to company inspections.
- Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
- Monitors trends in health authority inspection activities to proactively identify potential areas of risk for the company.
- Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific /function-specific summary report.
- Provides support to the IR Program Manager.
- Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
- Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.
EXPERIENCE AND QUALIFICATIONS:
- Minimum of a Bachelors degree in a scientific or health-related field with at least 5 years of relevant industry experience
- Minimum of 2 years in quality assurance/compliance required with a working knowledge of GCP and PV regulations.
- Prior auditing and/or or health authority inspection experience highly desired.
- General computer proficiency (e.g., Microsoft Office Suite applications).
- Proven project management skills
- Ability to work both independently and in a team environment
- Strong communication skills; verbal and written
- Critical thinking and decision-making skills
- Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently
- Prior participation in GCP and/or PV inspections is desirable
- GCP experience required for consideration.
To apply for a position send your resume to Jobs@JGBBioPharma.com
6) (Senior) Director Pharmacovigilance – Full Time Position (San Francisco Bay area) P54GT
DESCRIPTION:
Responsible for safety evaluation and risk management activities for marketed and investigational products. This includes leadership and strategic contribution to development risk management plans, and marketed product risk management and Pharmacovigilance plans. Function with minimal supervision as the head of safety evaluation to handle complex safety issues with a significant level of independence.
- Medical review of individual case safety reports for marketed and investigational products.
- Participation in signal detection meetings and work up of possible safety signals identified.
- Review of data for possible safety signals.
- Preparation of risk assessment reports.
- Review and investigation of possible product quality issues in collaboration with the product complaint department.
- Preparation of aggregate reports, including periodic safety update reports (PSURs) and development safety update reports (DSURs) for assigned products.
- Patient Safety representative for clinical sub-team for assigned products in clinical development
- Keep patient safety leadership informed of significant marketed product and clinical program safety issues.
- Collaborates with stakeholders regarding product labeling and accompanying information to promote and facilitate appropriate use of MedImmune products.
- Occasional ad hoc cross functional assignments, including process development.
EXPERIENCE AND QUALIFICATIONS:
- Doctor of Medicine with board certification or board eligibility; or PharmD or other related degree with minimum of 7 years pharmaceutical pharmacovigilance/ safety experience.
- Neurology therapeutic area experience preferred.
- A minimum of 10 years must be in the biopharmaceutical industry, with 5 years experience in pharmacovigilance.
- Prior experience in clinical safety including all phases of clinical development and registration experience (BLA, NDA, or MAA) is highly desirable.
- Demonstrated ability to provide meaningful input to protocol development and interpret clinical data from a safety perspective is highly desirable.
- Specific experience in clinical epidemiology, drug or vaccine development, public health epidemiology or hospital epidemiology is a plus.
- Demonstrated ability to understand epidemiological data and perform risk assessment analysis of adverse events.
- Position includes communication of safety information and analysis within the medical organization in addition to regulatory authorities and the medical community, good communication skills (verbal and written) are required.
- Ability to work in a team environment.
- Assessment of individual case safety reports and analysis/evaluation of aggregate safety data.
- Strategic risk management planning.
- Specific prior therapeutic area research experience is highly desirable.
To apply for a position send your resume to Jobs@JGBBioPharma.com
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