AbbVie Senior Analyst, Pharmacovigilance in Shanghai, China
Senior Analyst, Pharmacovigilance
China, Shanghai, Shanghai
Adverse Event Reporting:
Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PPS from spontaneous and solicited sources.
Ensures comprehensive data collection and follow-up for all case types including Post-Marketing Observational Studies (PMOS).
Ensures local language medical or scientific literature are reviewed to identify possible adverse events or special situations reportable to PPS, and that any reports are reported in a timely manner to PPS.
Ensures that local processes are in place for translating and formatting CIOMS form into local language and local regulatory format, and that any reports are reported in a timely manner to local authority.
Implements an appropriate local QC procedure to ensure quality of information entered in Affiliate AE tracking log, cases sent to PPS and of reporting decisions to local regulatory authority.
Aggregate Safety Reporting :
- Co-ordinates Affiliate review and submission of PSURs and other locally required Aggregate Safety Reports.
Reconciliation of Safety Data and Product Complaints:
Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures and forwards any AEs identified to PPS.
Completes AE reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.
Organized Data Collection Programs (including Patient Support, Market Research, and Social Media Programs):
Ensures that all Organized Data Collection Programs are assessed for impact to adverse event generation and PV requirements are in place and in line with Global and Local SOPs.
Ensures that any new programs or any significant changes in existing programs are tracked and updated in the ODC inventories.
Ensures that proposed audits of Organized Data Collection Programs service providers/vendors are communicated to AVE and R&D QA PV Compliance prior to audit.
Safety Data Exchange Agreements (SDEA) and other PV Agreements:
Maintains compliance with local agreements, and ensures the content of local SDEA and other PV agreements conforms to AbbVie standards and local requirements.
Responsible for requesting or providing a copy of all adverse event files for local product acquisition and divestitures.
Ensures all Affiliate employees and contractors in Affiliate are aware of their responsibility to complete annual AE identification and reporting training. Ensures this training is completed.
Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken at least annually, and that appropriate training records are maintained.
Ensures evidence of compliance related to this training.
Ensures that any training of partner company staff is completed according to local contracted requirements, and appropriately documented.
Audits and Inspections:
Acts as one of the key Affiliate contacts for both internal PV audits and Regulatory Authority PV inspections.
Ensures that any Regulatory Authority communications are forwarded to the required PPS personnel and that any responses / corrective actions are completed according to schedule.
Reviews all Risk Management Plans and PSURs to obtain information on the risk/benefit profile of products.
Ensures local RMP Plans are appropriately designed and implemented. Ensures risk minimization activities are properly tracked.
Ensures an Exception Report / CAPA process is in place to manage any non-conformity.
Monitors, notifies and assesses all draft and final hard PV intelligence in line with global timelines and requirements.
Ensures local deviation procedure is in place to document necessary planned departures from global and local PV related procedures.
After Hours Availability:
Ensures that an after-hours process is in place, tested at least once every 3 months and results are documented.
Maintains up- to-date information on local Regulatory Authority out of hour’s contacts.
- Ensures that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV. The plan should include provisions for events that could severely impact the organization’s staff and infrastructure in general or on the structures and processes for PV. This includes back-up systems for urgent exchange of information within an organization, amongst organizations sharing pharmacovigilance tasks and between marketing authorization holders and competent authorities.
Medical, pharmacy or life-sciences degree (or equivalent).
Minimum of two years’ experience working in the pharmaceutical industry in a drug safety role is strongly preferred.
Excellent written and spoken communication and presentation skills.
Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions.
Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority.
High customer orientation
Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.