Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

PRIMARY FUNCTION:
Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (drug safety) to ensure that all of AbbVies statutory and ethical responsibilities are met. Act as the Affiliates main contact point for pharmacovigilance matters with the National Regulatory Authority and AbbVie Pharmacovigilance and Patient Safety (PPS).

RESPONSIBILITIES:

Oversight of Pharmacovigilance:
1. Maintains oversight of all required PV regulatory reporting compliance in a timely manner
2. Provides comprehensive compliance metric reports to the Medical Director to ensure full visibility of compliance issues
3. Advises the business on the PV impact of local ODC programs (e.g. patient support programs)

Quality System / Standard Operating Procedures (SOPs):
1. Ensures local processes and procedures are in place to clearly define PV responsibilities within the Affiliate in line with Global SOPs and local regulations.

Compliance:
1. Ensures an Exception Report / CAPA process is in place to manage any non-conformity.
2. Ensures a local tracking system is in place, to ensure timely submissions of adverse events to AbbVie PPS.
3. 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.
4. Maintains awareness of local post-marketing and clinical PV legislation
5. Monitors, notifies and assesses all draft and final hard PV intelligence in line with global timelines and requirements.
6. Co-ordinates Affiliate review and submission of all periodic safety reports.
7. Completes AE reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.

Adverse Event Reporting:
1. 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.
2. Ensures local language medical or scientific literature, not included in PPS global literature review, 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.
3. Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to and if necessary, performed by redaction of patient information from Adverse Event Forms, medical records i.e., discharge summaries, physician notes, laboratory data information, etc. before information is transmitted to PPS.
4. Implements an appropriate local QC procedure to ensure quality of cases sent to PPS and of reporting decisions to local regulatory authority.

Reconciliation of Safety Data and Product Complaints:
1. Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures and forwards any AEs identified to PPS.

Organized Data Collection Programs (including Patient Support, Market Research, and Social Media Programs):
1. Ensures that all Organized Data Collection (ODC) Programs are assessed for impact to adverse event generation and PV requirements are in place and in line with Global and Local SOPs.
2. Supports local QA and global to conduct vendor audits and complete vendor CAPs

Safety Data Exchange Agreements (SDEA) and other PV Agreements:
1. Maintains compliance with local agreements, including reconciliation between partner companies.
2. Ensure the content of local SDEA and other PV agreements conforms to AbbVie standards and local requirements.

Training:
1. Ensures training compliance with Global and Local PV training requirements
2. Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis
3. Ensures that any training of partner company staff is completed according to local contract requirements, and appropriately documented.

Audits and Inspections:
1. Acts as the key Affiliate contact for both internal PV audits, audit of service providers and Regulatory Authority PV inspections.
2. Ensures that any Regulatory Authority communications are forwarded to the required global personnel and that any responses / corrective actions are completed according to schedule.

Risk Management:
1. Is a member of the Affiliate Risk Management Team
2. Reviews all Risk Management Plans and PSURs to obtain information on the risk/benefit profile of products.

Safety Monitoring:
1. Monitors the risk/benefit profile of local products and communicates changes or concerns to PPS Product Safety Team Lead and the QPPV (for products marketed in the EEA) for evaluation.

After Hours Availability:
1. Ensures that an after-hours process is in place, tested on a regular basis and results are documented.
2. Maintains up- to-date information on local Regulatory Authority out of hours contacts.

Business Continuity:
1. 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.

INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
Affiliate medical, regulatory affairs, quality assurance and customer service personnel.
Affiliate Marketing, Sales and Operations personnel in order to ensure that all employees are trained and understand their responsibilities for reporting of any suspected adverse event.
National Regulatory Authority responsible for product safety.
Global PV and JAPAC PV Point of Contact in International Pharmacovigilance Operational Excellence (IPEx) team.
Healthcare Practitioners, consumers and patients.

AUTHORITY AND REPORTING LINES:
PV Manager

LOCATION:
Affiliate head office based

Qualifications
IDEAL CANDIDATE:
Medical, pharmacy or life-sciences degree (or equivalent) preferred
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.

* . .

Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.