Pharmacovigilance Scientist Job Description
Pharmacovigilance scientist
provides assistance to case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases.
Pharmacovigilance Scientist Duties & Responsibilities
To write an effective pharmacovigilance scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included pharmacovigilance scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Daily activities involve
Have in-depth product knowledge, serve as product point of contact, and support Safety Management Team deliverables
Partner with team members, stakeholders including Medical Safety Officer (MSOs), and a vendor
Strategically plan and ensure timely, quality reports/safety analyses related to core deliverables
Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development for aggregate safety reporting
Independently perform and/or lead aggregate safety analysis and case level review and write, contribute to, and coordinate the preparation of core safety deliverables
Complete complex product reports where coordination and leadership of multiple scientists are required
Ensure commitments (e.g., PV Agreements, assessment reports) are met
Work closely with management to proactively support Therapeutic Area related business
May serve as Therapeutic Area Lead back up
Pharmacovigilance Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Education for Pharmacovigilance Scientist
Typically a job would require a certain level of education.
Employers hiring for the pharmacovigilance scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Pharmacy, Life Sciences, Health, Health Care, Natural Science, English, Science, Medical, Education
Skills for Pharmacovigilance Scientist
Desired skills for pharmacovigilance scientist include:
Applicable clinical trial safety regulations and post-marketing safety regulations
Common data processing software
PV regulations
Clinical trial methodology
Drug safety and risk management
Pharmacovigilance regulations
Safety profile and risk/benefit analysis
Common data processing software and database systems
Understanding of drug development
US and EU pharmacovigilance regulatory requirements
Desired experience for pharmacovigilance scientist includes:
Provide enhanced Safety Management Team (SMT) support to enable proactive safety management and act as core member of the SMT for assigned products
Deliver innovative solutions for aggregate safety strategy and analyses and ensure high quality reports
Have in-depth product knowledge, serve as product point of contact, and will support Safety Management Team deliverables
Work closely with Therapeutic Area Lead to support the therapeutic area business
Lead collaboration with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development and oversee execution
Complete and coordinate complex product reports
Pharmacovigilance Scientist Examples
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Pharmacovigilance Scientist Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of pharmacovigilance scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for pharmacovigilance scientist
- Act as core member for assigned products
- Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate
- Provide complete PVRM product life-cycle support for assigned product(s)
- Serve as Pharmacovigilance resource to clinical and post-marketing cross functional teams
- Collaborate with clinical and post-marketing teams to foster communication of potential safety concerns
- Participate in the development of protocols, annual updates to the compound-specific safety reference documents (Investigator’s Brochure, core safety information, etc), contribute and review Informed Consent Forms (ICF), ensure safety oversight in cooperation/leadership of the clinical trial medical team, represent PVRM in SAE reconciliation, final CSR narrative writing/review and contribute to the review of the final clinical safety report (CSR)
- Perform study-start activities, as necessary
- PVRM Liaison with Merrimack medical information team, Merrimack quality, and Merrimack Medical Affairs, and commercial team
- Acts as primary author/reviewer for assigned product aggregate periodic reports such as the DSUR, PADER, PBRER and others
- Perform on-going individual case quality review of representing company review in accordance with study Safety Management Plans, Safety exchange agreements and Merrimack SOPs
Qualifications for pharmacovigilance scientist
- Knowledge and experience in infectious diseases and/or vaccines is preferred
- Ability to effectively present to cross-functional teams is required.Drug & Product Safety Science
- Ability to effectively present to cross-functional teams is required
- Provide clinical, regulatory and technical pharmacovigilance exper-tise to DS&E medical function & DS&E leadership
- Lead the preparation of aggregate safety reports for newly launched Novartis products to meet regulatory requirements
- Alert the Medical Safety Physicians to potential safety issues recog-nized through single case medical review or aggregated data sets
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Pharmacovigilance Scientist Job Description
Job Description Example
Our company is hiring for a pharmacovigilance scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for pharmacovigilance scientist
- Identify data entry errors, document these errors and effectively communicate with CRO on findings
- Identify case management processes that are inconsistent or not well defined and communicate this to the PVRM team/supervisor
- Monitor and communicate with Merrimack clinical team regarding cases that have exceeded the internal case flow timelines
- Liaise with other Merrimack functions and participate in staff training, as needed
- Develop expertise in assigned products and therapeutic area
- Respond or coordinate response to standard and ad hoc safety queries
- Alert appropriate management as soon as a potential signal or trend is recognized
- Serve as a compliance role model that is consistent with the mission, vision and values of the organization
- Other items, as needed
- Trains and mentors junior members of the team, in approved PV processes, analytic methodologies
Qualifications for pharmacovigilance scientist
- Knowledge and experience in more than one therapeutic area is preferred
- Serve as a member of Global development and post approval core team’s subcommittee & teams
- Provides oversight of SAE reconciliation activities between the clinical and safety databases in accordance with SOPs
- Reviews and provides input and support with other departments (e.g., clinical operations, medical information, regulatory affairs, medical affairs, commercial CRO and data management) groups on PV related topics for study protocols, statistical analysis plans and other clinical related documents
- Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, study protocols, CRFs, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control
- Responsible for project managing and authoring of safety documents (SMTs, CSRs, GSC, PBER, DSUR and ad hoc requests, etc) in collaboration safety physicians (RMLs)
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Pharmacovigilance Scientist Job Description
Job Description Example
Our growing company is hiring for a pharmacovigilance scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for pharmacovigilance scientist
- May contribute to Regulatory benefit-risk assessments requiring a GCSP team approach
- Provides support and input into Clinical Development planning activities, with guidance
- With guidance, may represent GCSP on cross-functional Clinical Matrix Teams and/or Project Teams for developmental compounds
- Reviews and may provide technical approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters
- Assists in establishing Safety Review Teams and provides data for review and discussion
- Lead teams in preparing, organizing, and reviewing tabulations for Regulatory reports
- Contribute to definition of safety reporting requirements in clinical study protocols and Safety Management Plans
- Contribute to expectedness lists for development and marketed products in clinical studies
- Support PV physician in review of SAEs and non-serious adverse events from interventional clinical and from non-interventional post-marketing studies
- Provides assistance to case processing team in data entry of clinical trial SAEs into Argus safety database and to medical coding of adverse events and diseases
Qualifications for pharmacovigilance scientist
- Experience in MedDRA coding and search strategies
- Strong people and project leadership skills
- Strong organizational and prioritization skill
- Excellent analytical and problem solving sills
- Understanding of clinical development processes related to clinical trials preferred
- Minimally, Bachelor’s degree (or equivalent) in health-care related field (strongly preferred) with Oncology experience preferred
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Pharmacovigilance Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of pharmacovigilance scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for pharmacovigilance scientist
- Submit/provide MedWatch/CIOMS I/E2b reports as applicable
- Providing therapeutic area PV support for Moderna’s developmental products in close collaboration with senior PV, Clinical and Medical personnel
- Oversight of day to day PV operational activities for Moderna’s investigational products
- Oversight of vendor case management and continued process improvement
- Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents
- Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas
- Assist in usual pharmacovigilance activities including ongoing signal monitoring, benefit/risk assessment, regulatory activities and interactions
- Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities
- Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate
- Participate in writing of aggregate safety reports (e.g., DSURs), as required
Qualifications for pharmacovigilance scientist
- Demonstrated proficiency in global regulatory requirements, guidelines and industry best practices for pharmacovigilance with experience in safety related organized data collection, analysis and reporting (e.g., interventional and non-interventional clinical trials, registries, patient programs, market research programs)
- Minimum of three years industry experience with minimum of five years post-marketing PVRM experience
- Minimally a basic working understanding of drug/device safety filing procedures competent knowledge of domestic and international regulatory requirements highly desirable
- Must be experienced with standard word processing, spreadsheet, and safety data base packages (Argus preferred)
- Proven ability to critically think through complex medical/safety reports and effectively summarize key information in a concise narrative presentation
- Flexible, highly organized with the ability to prioritize and detail oriented
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Pharmacovigilance Scientist Job Description
Job Description Example
Our growing company is looking to fill the role of pharmacovigilance scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for pharmacovigilance scientist
- Assist with writing and maintenance of Safety Monitoring Plans and Safety Data Exchange Agreements
- Oversight of signal evaluation/safety monitoring activities
- Assure oversight for the review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data
- Provide pharmacovigilance (PV) data analysis and writing expertise as required for preparation of a range of US and global regulatory reports, including PBRER, PSURS,INDSRS and Signal Detection issues
- Responsible for data compilation, validation, evaluation and written conclusions for aggregate safety documents consistent with Company and global regulatory requirements
- Perform signal triage using medical judgment
- Prepares aggregate reports summarizing safety data, making conclusions about safety signals (or lack thereof)
- Direct the planning, preparation, writing and review of portions of aggregate reports
- Support and provide oversight to staff with regards to safety in clinical trials
- Review of Adverse Events or Serious Adverse Events (AEs/SAEs) from clinical trials
Qualifications for pharmacovigilance scientist
- Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), with external colleagues
- A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
- Supports GPV team for its compliance goals with regards to data collection, analysis, reporting standards and operational consistency across interventional, non-interventional trials, IITS
- Collaborates with Clinical Operations, Data Management, Clinical CRO and Study Teams in development of the safety related data collection forms, table design, and listings for safety data from interventional/non-interventional trials
- Servers as a primary reviewer on safety/PV related topics for study protocols, statistical analysis plans and other clinical related documents and provides input an collaborate with other departments (e.g., clinical operations, medical information, regulatory affairs, medical affairs, commercial CRO and data management)
- Writes the safety section in collaboration with team members on regulatory responses, IBs/CCDS, study protocols, CRFs, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control