Safety Scientist Resume
Headline : As a Safety Scientist, manage local Pharmacovigilance, Medical Information, and Product Quality Complaint activities tied to the LQPPV role, customer and client-facing. This includes but is not limited to the local literature review, local intelligence review, and management of local PV, MI, and PQC cases coming in via email and phone.
Skills : Knowledge of pharmacovigilance and drug safety regulations, Proficiency with safety databases and adverse event reporting systems.
Description :
- Ensured safety concerns are appropriately addressed and communicated to TGA.
- Responsible for responses to Health Authorities’ requests and responses to inquiries from internal and external customers.
- Responsible for mentoring more junior colleagues, development of processes/tools/systems, and may serve as lead on smaller FSP-type projects.
- Conducted quality reviews for signal detection and product safety scientist tasks that are low to high in complexity or which concern low to high complexity products.
- Advised clients on safety-related issues under supervision by a more experienced team member.
- Supported training and mentoring of junior colleagues.
- Worked within multiple company and client systems.
Experience
5-7 Years
Level
Executive
Education
BPharm
Senior Safety Scientist Resume
Summary : As a Senior Safety Scientist, assist with the ongoing workload supporting their global client and working closely with clients MDs. Activities include post-marketing signal detection and signal management, input and review of risk management plans, aggregate safety reports, support of regulatory requests, and global and local labeling.
Skills : Understanding of clinical trial processes and regulatory submissions.
Description :
- Performed proactive safety monitoring and signal detection for marketed products including signal identification, evaluation, and interpretation of safety signals and prioritizing signals for full evaluation.
- Completed initial assessment of safety signals and prepared a draft interpretation of reviewed data for assessing safety signals.
- Evaluated and prepared documents to answer internal and/or external requests on safety data including the IB, labeling, aggregate reports, and regulatory submissions.
- Planned and executed literature surveillance as needed.
- Reviewed RMP/REMS including aRMMs and provided input as needed.
- Provided input and review for aggregate reports for submission to the health authorities and other stakeholders, as needed.
- Reviewed Regulatory Authority Websites about signal information.
Experience
7-10 Years
Level
Senior
Education
BSN
Junior Safety Scientist Resume
Objective : As a Junior Safety Scientist, responsible for the planning, coordination and delivery of signal detection and product safety scientist activities, with a focus on tasks that are low to high in complexity or which concern low to high complexity products.
Skills : Proficiency in data analysis software, Statistical tools.
Description :
- Interacted with project team members and clients.
- Ensured that tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
- Participated in departmental initiatives and served as a subject matter expert in designated areas.
- Worked on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Had wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Determined methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
- Exercised judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Experience
2-5 Years
Level
Junior
Education
MBBS
Associate Safety Scientist Resume
Objective : As an Associate Safety Scientist, serves as a creator/contributor for signal detection and product safety scientist tasks that are ultra-high in complexity or which concern ultra-high complexity products, under supervision by a more experienced team member.
Skills : Analytical Skills, Strong Problem-solving skills.
Description :
- Developed safety communication documents and aggregate safety reports.
- Responsible for Signal Tracking and Deviation Management with safety-related activities (RMP).
- Organized, trained, and supported junior safety scientists and fellows across multiple product portfolios and/or indications.
- Co-led activities related to new drug applications and other regulatory filings.
- Represented global patient safety at regulatory inspections MHRA, FDA, and EMA.
- Led analysis to identify and address changes in global regulations including updates to SOP and process documentation.
- Responsible for leading activities to identify and address process gaps.
Experience
0-2 Years
Level
Entry Level
Education
BSc
Assistant Safety Scientist Resume
Headline : As an Assistant Safety Scientist, responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.
Skills : Ability to identify, assess, mitigate risks.
Description :
- Supported post-marketing risk management activities (RMP, aRMM).
- Supported generation of periodic reports (PSUR, Regional aggregate reports) and responses to health authority requests.
- Collaborated with Product Safety Lead for set-up and analysis of Post-marketing studies/registries.
- Supported the PSMF generation for product-related information.
- Supported for implementation of a strategy for risk minimization.
- Supported product safety physician for signal detection.
- Developed a strategy for communication of safety information.
Experience
5-7 Years
Level
Executive
Education
BPharm
Safety Scientist Resume
Summary : As a Safety Scientist, provide scientific expertise and support proactive safety surveillance and risk management activities in conjunction with the Product Safety Lead Physician for the cross-functional team(s) in support of benefit-risk profile during the post-marketing phase.
Skills : Capability to perform benefit-risk assessments, Communication Skills.
Description :
- Responsible for vendor management and training including budgets.
- Responsible for overall project distribution across therapeutic area.
- Represented GPS in global program teams and associated cross-functional teams and/or projects.
- Proactively provided guidance and educational training to GPS therapeutic teams.
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
- Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors.
- Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration safety physicians.
Experience
10+ Years
Level
Management
Education
BSN
Safety Scientist Resume
Summary : As a Safety Scientist, plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework.
Skills : Strong interpersonal skills, Detail-Oriented.
Description :
- Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provided the necessary quality control to ensure alignment with core safety position.
- Managed portfolio of products/projects related to risk management.
- Assisted Safety Physicians in the development of risk management strategy and activities for assigned products.
- Led the monitoring of the safety of patients on allocated clinical trials.
- Led the development of safety contents and contribute to Data Monitoring Committees or Safety Monitoring Committee.
- Led signal detection and related tasks which are high in complexity, or which concern high complexity product.
- Led execution of signal assessment strategy and assess potential impact to the product safety profile with recommendations for action.
Experience
7-10 Years
Level
Consultant
Education
BSN
Safety Scientist Resume
Objective : As a Safety Scientist, lead the preparation of safety-related sections and associated documentation for safety, clinical and regulatory documents, with appropriate assessment of impact, dependencies, and proposal for the Safety Management Team.
Skills : Attention to Detail, Thoroughness in documenting safety assessments and decisions.
Description :
- Led signal assessment and documentation following BeiGene signal management and safety governance framework.
- Demonstrated ability to strategically apply PV principles and regulations to related tasks that are high in complexity.
- Led safety science contributions, critically reviewed documents (Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs proactively resolved issues, proposed solutions, and escalated to PSL accordingly.
- Collaborated with Data Analytics, Biostats, and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports including DSUR, PBRER, and other required aggregate safety analyses required by regulatory authorities.
- Contributed/ authored to safety sections and review of aggregate safety reports.
- Authored and reviewed safety sections of regulatory submissions, IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members.
- Contributed high-quality content to Storyboards and Briefing Books for HA interactions.
Experience
0-2 Years
Level
Fresher
Education
MBBS
Safety Scientist Resume
Objective : As a Safety Scientist, contributes to the Safety sections for global regulatory submissions for new products, formulations, or indications, in partnership with the product physician and liaison with other functional experts (Clinical Development, Regulatory).
Skills : Regulatory Knowledge and familiarity with global regulatory requirements.
Description :
- Contributed to the authoring and maintenance of the Safety Surveillance Plans.
- Provided analysis and insight for integrated Benefit/Risk assessments.
- Actively contributed to product safety surveillance, coordinating aspects of signal evaluation/safety review activities, scheduled review of scientific literature, SAE listings, data-mining and data outputs from the safety database and the clinical database to identify potential risks, emergent safety issues and signals.
- Led evaluation of safety topics and issues and author safety assessment reports under author and maintain RSI for use in IBs.
- Contributed to the development and maintenance of the Company Core Safety Information (CCSI), propose edits, manage approval of amendments and contribute to safety summaries to support changes to the CCDS.
- Contributed to development of package Insert and labeling updates, develop labeling prose text updates, based on internal aggregated reports.
- Developed labeling update impact summaries, justification documents, and regulatory responses for use by RA for PI/ SmPC Type II variations.
Experience
2-5 Years
Level
Junior
Education
MBBS
Safety Scientist Resume
Objective : As a Safety Scientist, conducts or leads pharmacovigilance and risk management planning for designated products, contributes to benefit-risk assessments and prepares Risk Management Plans, in partnership with the product Safety Lead.
Skills : Understanding of Good Pharmacovigilance Practices, Organizational Skills.
Description :
- Contributed to the authoring and maintenance of core RMPs and local Risk Management Plans/ REMS.
- Assisted in leading and improving the oversight and monitoring of effectiveness of the risk minimization measures.
- Assisted in the internal and external dissemination of important new safety information or actions (DHCP/DHPC letters) and improvement of notification processes.
- Presented to the Safety Management Team (SMT) and actively participate and take minutes at Company Safety Committee (SCS) when required.
- Maintained and enhanced knowledge of safety profiles for allocated products, including both BeiGene and competitor products.
- Led the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates for regulatory inspections.
- Supported an environment of continuous improvement within the team and contributed to continuous improvement initiatives and inspection readiness across GPS.
Experience
2-5 Years
Level
Junior
Education
BPharm
