Pharmacovigilance Scientist Resume
Summary : As a Pharmacovigilance Scientist, collected, monitored, researched, assessed and evaluated information from healthcare providers and patients on the adverse effects of medications to ensure that drugs on the market are safe for patients and to identify new hazards associated with the medication.
Skills : Observational, Analytical, Problem-solving, Team working skills.
Description :
- Supported and led PVvendor management activities including day-to-day oversight, review, and evaluation of vendor performance and quality.
- Supported the drafting and updating of vendor-related plans.
- Supported the drafting of queries to clarify information received from ICSRs or product complaints.
- Participated in the development and maintenance of PV System policies, SOPs, forms, work instructions, and guidance documents
- Ensured operational compliance with global PV guidance and regulations.
- Collaborated withMedical Affairs, Commercial, or Marketing to develop processes, forms, and trainings.
- Undertaken activities necessary to maintain a state of inspection readiness.
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree In Pharmacy
Pharmacovigilance Scientist Resume
Summary : Over 7 years of experience in Pharmacovigilance, with a proven track record of ensuring the safety of pharmaceutical products. Proficient in signal detection, risk assessment, and regulatory reporting requirements, including FDA and EMA guidelines.
Skills : Mathematical skills, Project management, Planning.
Description :
- Identified data entry errors, documented these errors, and effectively communicated with CRO on findings.
- Identified case management processes that are inconsistent or not well defined and communicate this to the PVRM team/supervisor.
- Monitored and communicated with the clinical team regarding cases that exceeded the internal case flow timelines.
- Liaised with other functions and participated in staff training, as needed.
- Developed expertise in assigned products and therapeutic areas.
- Responded or coordinated responses to standard and ad hoc safety queries.
- Served as a compliance role model that is consistent with the mission, vision, and values of the organization.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree In Life Sciences
Pharmacovigilance Scientist Resume
Objective : As a Pharmacovigilance Scientist, participated in the preparation of safety-related response documents to regulatory authorities, ensuring the accuracy and completeness of safety sections of applicable clinical documents.
Skills : Proficiency in pharmacovigilance principles, Medical Terminology.
Description :
- Trained and mentors junior members of the team, in approved PV processes, and analytic methodologies.
- Identified possible side effects of drugs after they have been approved for use by the FDA.
- Reviewed reports about possible side effects from consumers or healthcare professionals.
- Tracked adverse events that occur after a drug has been released to the market.
- Conducted research to identify risk factors that may make certain medications unsafe for certain groups of people.
- Prepared reports on findings, which are then sent to the drug manufacturer, regulatory agencies, and medical community.
- Reviewed adverse events that occur after a drug has been approved for use by the FDA.
Experience
2-5 Years
Level
Executive
Education
Bachelor's Degree In Pharmacology
Pharmacovigilance Scientist Resume
Objective : As a Pharmacovigilance Scientist, responsible for authoring the safety section in collaboration with team members on regulatory responses, IBs/CCDS, study protocols, CRFs, Data Monitoring Committee reports and requests, and other documents, and providing the necessary quality control.
Skills : Data Analysis, Regulatory Compliance, Pharmaceutical Product Knowledge.
Description :
- Participated in post-marketing surveillance activities such as clinical trials or surveys.
- Participated in clinical trials as a patient volunteer or as a member of a research team.
- Monitored new drugs in development to determine whether they have any potential for serious side effects.
- Performed sponsor review of all serious and non-serious adverse events outsourced to our PV vendor.
- Scheduled meetings with the PV vendor and provided feedback on case quality and compliance.
- Ensured the timely submission of Adverse Events and notification of our marketing partners through our PV vendor.
- Reconciled adverse events with clinical database for IND studies and reviewed DSUR for completeness.
Experience
0-2 Years
Level
Junior
Education
Master of Science in Pharmacology
Pharmacovigilance Scientist Resume
Summary : As a Pharmacovigilance Scientist, provides assistance to the case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases.
Skills : Communication, Database Management, Risk Assessment, Quality Assurance, Teamwork.
Description :
- Performed reconciliation with business partners and vendors for AE report exchanges.
- Contributed to safety sections and review of aggregate reports, PBRERs, DSURs, and PADERs.
- Prepared and reviewed answers to safety queries from regulatory authorities as needed.
- Provided safety guidance regarding potential post-approval safety commitments, including non-interventional safety studies.
- Served as key analytic and safety support lead in close collaboration with the product safety physician for the assigned product(s).
- Contributed to signaling and data mining activities utilizing internal and external sources of data.
- Coordinated with Safety physician to lead Safety Committee meeting preparation and documenting of meeting minutes.
Experience
7-10 Years
Level
Consultant
Education
Bachelor's Degree In Pharmacy
Pharmacovigilance Scientist Resume
Summary : As a Pharmacovigilance Scientist, responsible for overseeing and leading the process of safety signal management process, authoring/contributing to aggregate safety reports (PSURs, DSURs.), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and conducting/overseeing Clinical Trial PV medical activities.
Skills : Biotechnology, Microbiology, Regulatory reporting.
Description :
- Performed sponsor review of serious adverse events outsourced to our PV vendor.
- Responsible for safety review of protocol and CRFs, safety content of IB, ICF, and other documents to appropriately support Clinical study activities.
- Prepared the safety responses to Health Authority/IRB/EC requests and questions.
- Represented PV on the clinical study team(s) to support the safety content for study documents such as protocol, ICF, safety management plans, eCRFs, and reconciliation plans.
- Provided support to the Product Safety Lead in activities relating to monitoring and management of emerging safety profiles for assigned product(s).
- Conducted signal detection and risk assessment activities to identify potential safety concerns, resulting in timely regulatory actions and label updates.
- Conducted in-depth signal detection and risk assessment to identify potential safety concerns, contributing to the development of risk management strategies.
Experience
10+ Years
Level
Senior
Education
Bachelor's Degree In Life Sciences
Pharmacovigilance Scientist Resume
Summary : As a Pharmacovigilance Scientist, responsible for conducting, monitoring, or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and avoiding adverse effects or side effects of marketed pharmaceutical products among the general population in research trials and hospitals.
Skills : Pharmacy, Biochemistry, Life sciences, Computer proficiency.
Description :
- Managed the collection, evaluation, and reporting of adverse events, ensuring compliance with international pharmacovigilance regulations.
- Collaborated with cross-functional teams, including Regulatory Affairs and Clinical Development, to provide safety insights during drug development phases.
- Coordinated the preparation and submission of periodic safety reports (PSURs, DSURs) to regulatory authorities.
- Implemented process improvements that enhanced efficiency in case processing and adverse event reporting.
- Assisted in the review and assessment of adverse event reports, ensuring accuracy and compliance with regulatory guidelines.
- Supported the development and maintenance of pharmacovigilance procedures and Standard Operating Procedures (SOPs).
- Trained junior pharmacovigilance staff on case processing, safety assessment, and regulatory compliance.
Experience
7-10 Years
Level
Management
Education
Bachelor's Degree In Pharmacology
Pharmacovigilance Scientist Resume
Objective : As a Pharmacovigilance Scientist, responsible for monitoring the safety of drugs and other pharmaceutical products. Reviewed reports of adverse events (including death) that may be related to a particular drug or product, and they also investigated any potential problems with manufacturing processes or quality control procedures.
Skills : IT skills, Teamwork skills, Mathematical skills.
Description :
- Contributed to the preparation of aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Risk Evaluation and Mitigation Strategies (REMS) documents.
- Participated in inspections and audits by regulatory authorities, providing necessary documentation and expertise.
- Led or participated in training sessions for internal teams to ensure a clear understanding of pharmacovigilance practices, safety reporting, and regulatory requirements.
- Identified and implemented process improvements to enhance efficiency in case processing, adverse event reporting, and signal detection.
- Conducted literature searches and assessments of scientific publications to stay informed about safety information related to pharmaceutical products.
- Processed and reviewed adverse event reports, ensuring data accuracy and completeness, and maintained thorough and up-to-date records of case documentation.
- Managed case processing and maintain a comprehensive database of adverse events, ensuring timely submissions to health authorities and adherence to quality standards.
Experience
2-5 Years
Level
Executive
Education
Master of Science in Pharmacology
Pharmacovigilance Scientist Resume
Objective : As a Pharmacovigilance Scientist, responsible for analyzing potential safety issues, including signal detection, signal evaluation, and signal management, coordinating and documenting all signal review activities.
Skills : Pharmacovigilance, Veterinary, Excellent communication skills.
Description :
- Ensured compliance with international pharmacovigilance regulations and guidelines, including those issued by the FDA, EMA, and other regulatory authorities.
- Conducted signal detection activities to identify potential safety concerns and emerging trends perform risk assessments and propose appropriate risk minimization strategies.
- Monitored and evaluated adverse events and safety data related to pharmaceutical products.
- Ensured the accurate and timely processing of safety reports, including serious adverse events.
- Performed signaling data review from all sources including but not limited to Empirica, Clinical and Safety outputs, Literature, and HA requests Responsible for evaluation and development of Safety Management Plans.
- Developed knowledge of capabilities and limitations of various data sources.
- Performed quality check of Aggregate reports/RMPs as per client requirements.
Experience
0-2 Years
Level
Junior
Education
Bachelor's Degree In Pharmacology
Pharmacovigilance Scientist Resume
Summary : As a Pharmacovigilance Scientist, supports both early and late-phase development activities, providing essential safety oversight and input into all aspects of signal management across the entire development portfolio.
Skills : Drug Safety Monitoring, Case Processing, Drug Development Process.
Description :
- Assisted in the evaluation of potential safety issues and quality risk assessment reports.
- Contributed to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes, and meeting documents.
- Ensured completion of action items and participated in the discussion of patient safety issues.
- Contributed to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Responsible for ensuring the global team can anticipate, develop, and support improved/consistent scientific ways of working to implement effective Patient Safety and Risk Management processes.
- Contributed as a member of the Drug Safety team to scenario planning, strategy analysis, portfolio prioritization, budget management, and forecasting.
- Managed and supported the authoring for aggregate safety reports (eg., PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions.
Experience
7-10 Years
Level
Consultant
Education
Master of Science in Pharmacology
