The Pharmacovigilance Scientist provides assistance to the Pharmacovigilance Physician in the monitoring of the safety profiles of assigned products and prepares various regulatory documents within agreed timeframes and to a high standard of accuracy, in compliance with GEHC business rules, standard operating procedures and global and local regulatory requirements.
Essential Responsibilities: Responsibilities include, but not limited to, the following activities:
Supports PV Physician in clinical review and evaluation of individual case safety reports (ICSRs) of SAEs and nonserious AEs occurring in association with assigned products.
Assists, upon request of the PV Physician, in the medical coding of events according to standard MedDRA terminology and in data cleaning.
Provides assistance to PV Physician in medical review of SAEs and nonserious AEs occurring during clinical development and postmarketing surveillance.
Interfaces with clinical team, under the direction of the PV Physician, for safety matters including follow-up of events of interest and in providing input into site queries regarding serious adverse events, as well as nonserious adverse events.
- Medical surveillance
Safety signal detection and evaluation
Devises on appropriate safety database search strategies in co-operation with the Manager, PV Safety Systems to proactively identify new safety issues or to further elucidate suspected safety issues from the medical literature.
Assists PV Physician in organizing and leading Safety Management Team (SMT) and Safety Review Team meetings.
Supports strategic and operational oversight of the management of evolving safety issues.
Provides support in compilation of information for reference safety information (including CCSI) and investigator's brochure.
- Aggregate reports
Co-authoring of Aggregate Reports and ad hoc Safety Reports.
Supports PV Physician in providing clinical input to detailed reviews of events of interest including those for inclusion in Aggregate Reports (PSURs, Addendum Reports, Summary Bridging Reports, US Periodic/ Annual Reports, ASRs, DSURs).
- Risk Management
Supports development of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans.
Assists the PV Physician in the maintenance of RMPs and REMS, including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures.
- PV compliance/training
Provides the PV Physician with support as required for licensing activities, regulatory authority inspections, and for project product recall activities.
Assists the PV Physician in the training and mentoring of internal and cross-functional team members.
- Support other functions
Supports preparation of ad hoc responses to regulatory authorities in response to specific queries from regulators.
Assists in providing responses to inquiries from internal sources, health care professionals, and other external sources.
Participates, under the direction of the PV Physician, in the review of clinical study protocol reports and other regulatory documents as necessary.
- Minimum of a Bachelor's degree in Nursing, Pharmacy, or similar field,
- Minimum 5 years of pharmaceutical and/or biotechnology industry or CRO experience, including Pharmacovigilance.
- Basic understanding of data mining in the evaluation of safety signals
- Skilled in assessment of post-marketing and investigational adverse events
- Strong working knowledge of applicable regulations and ICH guidelines.
- Experience in developing case series retrieval strategies.
- Experience with MedDRA coding.
- Basic understanding of pharmacovigilance-related information systems other than safety databases, such as health claims databases for the identification of safety signals using data mining techniques.
- Available for domestic and international travel
- Must be permitted to work in USA
- Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal
history, and educational background
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
- Knowledge of other languages desirable.
- Ability to work collaboratively with PV Physicians in all pharmacovigilance-related activities.
- High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment and assume the role of “player/coach” as necessary
- Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills
- Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship desirable.
- Prior experience in pharmacovigilance and risk management strategies regarding products under increased regulatory scrutiny and in assisting PV Physicians in providing the medical safety content of all documents required to implement and monitor the progress of risk management plans and responses to ad hoc safety issues to regulatory authorities.
- Knowledge and understanding of safety database search strategies to support the Pharmacovigilance Physician in the identification and evaluation of safety signals.