PRIMARY FUNCTION / OBJECTIVE :
Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (drug safety) to ensure that all of AbbVie’s statutory and ethical responsibilities are met.
Act as the Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Authority and AbbVie Pharmacovigilance and Patient Safety (PPS).
CORE JOB RESPONSIBILITIES :
Maintains oversight of all required PV regulatory reporting compliance in a timely manner
Ensures an Exception Report / CAPA process is in place to manage any non-conformity.
Ensures a local tracking system is in place, to ensure timely submissions of adverse events to AbbVie PPS
Ensures reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic Reports to the Regulatory Authority and Ethics Committees as required.
Maintains awareness of local post-marketing and clinical PV legislation
Reviews and confirms regulatory reporting requirements at least annually
Co-ordinates Affiliate review and submission of all periodic safety reports.
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 and Serious Adverse Events (SAEs) from clinical studies.
Ensures comprehensive data collection and follow-up (e.g. lot / batch #, age or age group, medically relevant information) for all case types including Post-Marketing Observational Studies (PMOS).
Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures and forwards any AEs identified to PPS.
Maintains compliance with local agreements, including reconciliation between partner companies.
Submits other local PV Agreements to PPS for review prior to finalization, in the event these agreements contain variations from the PV Agreement Language templates.
Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis; that appropriate training records are maintained.
Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.
Review of individual reports, local literature and clinical trials, as required by local regulations for trends and issues arising from reports received.
Alert management of any relevant issues.
Review local and global SOPs and pharmacovigilance guidelines.Communicate to management and AbbVie Product Safety Areas any important changes.
Acts as Affiliate Safety Representative (ASR) or as back-up ASR in assigned countries
PREFERRED QUALIFICATIONS :
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 for the Affiliate Safety Representative role but is less critical for the backup ASR role.
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.
Travel : No
Job Type : Experienced
Schedule : Full-time
Job Level Code : IC