Senior Drug Safety Specialist [Taiwan]

 

PRIMARY FUNCTION/OBJECTIVE
Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance (PV) to ensure
that all of AbbVie’s statutory and ethical responsibilities are met.
CORE JOB RESPONSIBILITIES
Leadership and management

• Build and maintain effective business relationships across the affiliate to support the implementation

of patient safety standards.

• Seek continuous improvement to optimize the affiliate PV system and contribute to regional and global

process improvement initiatives, working with PPS subject matter experts.
PV operation
Responsible for below tasks:

• Monitoring monthly PV dashboard and PV metrics data entry timeline, data quality and accuracy. If any

compliance issue detected, must report to ASR.

• Accountable for clinical trial related tasks including but not limited: AE, SAE, SUSAR, reporting and

reporting requirement, Blind SUSAR communication, trial tracking log maintenance, ensure investigational compound captured in AEGIS, assigned as PV point of contact to SMM team.

• Monitoring new product launches and product expansion in launch readiness tasks.
• Performing quarterly ODC program monitoring.

Adverse Event & Periodic Safety Reporting

• Ensure that processes, procedures and systems are in place for intake, processing, conducting follow up,

translating and reconciling adverse events and other safety information reportable to PPS from
spontaneous and solicited sources and from clinical studies.

• Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic

and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with
corporate PV procedures and with local and regional PV regulations as required.
Partnership with business partner with possibility for identification and/or handling of safety
information

• Partner with Program Owners and commercial leaders to ensure that all business partnerships involving

activities where there is a reasonable possibility for the identification and/or handling of safety
information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.
Safety Data Exchange Agreements (SDEA) and other PV Agreements

• Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and

local requirements and maintains the inventory in the PPS PV Agreements Database.

• Maintain and monitor compliance with local agreements.

Audits and Inspections

• Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
• Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.

Risk Management

• As a member of the Affiliate Risk Management Team (ARMT), review Risk Management Plans (RMPs)

and implement risk minimization measures at the affiliate according to AbbVie procedures and local
requirements.

• Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.
• Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if

applicable, liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision
of local documents.

• Partner with ARMT & Benefit Risk Management (BRM) Team during development or revision of the

Local Implementation Plan (LIP) & local additional risk minimization measures.
After Hours Availability & Business Continuity

• Ensure that an after-hours process is in place for the reporting of AEs.
• Ensure 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, clinical, quality assurance and customer service personnel.
• Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and

understand their responsibilities for reporting of any safety information.

• National Regulatory Agency responsible for product safety.
• Pharmacovigilance and Patient Safety, including but not limited to IPEx, Area PV Product Lead, Benefit-

Risk Management and QPPV Office.

• Healthcare Practitioners, consumers and patients.

PREFERRED QUALIFICATIONS

• Medical, pharmacy or life-sciences degree (or equivalent).
• At least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is
• required.
• Excellent written and spoken communication and presentation skills.
• Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance

and Patient Safety, Area/Regional Medical and other headquarters functions.

• Fluency in written and oral local language a requirement to facilitate communications within the

affiliate medical department, and with the National Regulatory Agency.

• 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.

Critical Success Factors

• Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Affairs, Regulatory Affairs, Commercial) and PPS and tailors communication to different stakeholders to enhance understanding of PV requirements and elevate the PV internal brand.
• Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly

where indicated to add value to the PV system.

• Acts consistently with AbbVie’ s ethics, obligations and local laws – putting patient safety, partnerships

and overall AbbVie’s interests before individual, immediate team and functional interests.

• Focused on compliance; identifies, manages and escalates issues in a timely manner.
• Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk

information to area and affiliate stakeholders to positively impact business strategies.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.