Title:

Main: Medical Advisor,Bosnia and Herzegovina and Affiliate Safety Representative Bosnia & Herzegovina

Back-up: Quality Assurance & Medical Advisor ADRIA

Affiliate: Bosnia & Herzegovina

FULFILS RESPONSIBILITIES:

Main: Medical Advisor, Bosnia and Herzegovina and Affiliate Safety Representative Bosnia & Herzegovina

Back-up: Quality Assurance & Medical Advisor ADRIA

This position primarily represents the affiliate’s medical/scientific voice of expertise for assigned product(s) and relevant therapeutic areas as well as the Affiliate Safety Representative for Bosnia & Herzegovina. However in case of a company need may act also in other roles within Medical Affairs in accordance with company standards.

JOB RESPONSIBILITIES:

Medical Advisor

  • Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s)through attendance / participation at key internal meetings/training sessions, relevant congresses,and seminars and by regular self-study of the national/international literature.
  • Provide expert medical/scientific advice for assigned products and related therapeutic areas, includingresponding to requests for scientific/technical information; contribute to the development and medicaland scientific accuracy of core dossiers generated by the medical department (i.e. pricing andreimbursement dossiers, HEOR dossiers, medical information packs, clinical expert reviews etc).
  • Establish and maintain professional and credible relationships with key opinion leaders and academiccenters; this will involve participating in scientific congresses, coordinating advisory boards, roundtablemeetings, discussion fora etc.
  • Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.), where requested.
  • Screen relevant literature and other information from relevant scientific societies meetings andconferences and develop summaries of key messages for use within the Company (e.g. key areas ofscientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeuticarea, etc.)
  • Deliver training to sales forces and other departments; develop and update relevant training materials.
  • Review of promotional material. Ensure the medical/scientific content is correct and fully compliant with AbbVie’s internal policies and guidelines.
  • Provide medical/scientific input into marketing strategy and key commercial initiatives, as required.
  • Monitor the environment for competitive intelligence (e.g. product strategies, studies, commercial messages, positioning, etc.) and communicate, where appropriate, within the Company.

Affiliate Safety Representative

Act as affiliate ASR, fulfilling National Regulatory Authtority regulations with respect to pharmacovigilance (PV), and conform to company standards.

  • Quality System/SOPs:
  • Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate SOPs and local regulations.
  • Compliance:
  • Ensures a local tracking system is in place, to ensure timely submissions of adverse events to Global Pharmacovigilance (GPV), and of ICSRs and Periodic Reports to the Regulatory Authority.
  • Reports monthly compliance metrics and information to GPV or R&D QA PV Compliance within the required timelines.
  • Maintains awareness of local PV legislation.
  • Ensures GPV, minimally GPV Quality Systems, Contracts and Training Operations (QSCTO) and Affiliate Vigilance Excellence (AVE) is promptly notified of any changes to relevant Local Legislation.
  • Ensures formal documentation and notification to AVE and GPV of local reporting requirements for both ICSRs and aggregate reports, provides updates to these requirements per changes in local legislation and reviews and confirms these requirements at least annually.
  • Co-ordinates Affiliate review and submission of periodic safety reports.
  • Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.
  • Ensures any changes to Affiliate safety personnel are communicated to the Regulatory Authority (if required by national legislation), GPV, Affiliate Vigilance Excellence (AVE) and the Qualified Person for Pharmacovigilance (QPPV) (if applicable) in a timely fashion.
  • Ensures local Deviation procedure is in place to document necessary planned departures from Global and Local PV related procedures.
  • Ensures approval by GPV QSCTO Director and R&D PV QA Compliance for deviations to Global PV related procedures.
  • Notifies GPV QSCTO Director and R&D PV QA Compliance of deviations to Local PV related procedures.
  • Adverse event processing:
  • 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 GPV from spontaneous and solicited sources and 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 Postmarketing Observational Studies (PMOS).
  • Ensures local language medical or scientific literature, not included in GPV global literature review, are reviewed to identify possible adverse events or special situations reportable to GPV, and that any reports are forwarded in a timely manner to GPV.
  • 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 GPV.
  • Product Complaints:
  • Ensures product complaints are reviewed for adverse events, and forwards any AEs identified to GPV.
  • Completes reconciliation between QA and PV at the Affiliate, ensuring that all ICSRs have been identified.
  • Organized Data Collection Programs (Patient Support Programs, Market Research Programs, 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 GPV program inventory.
  • 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 (SDE) Agreements:
  • Maintains compliance with local agreements, including reconciliation between partner companies.
  • Ensure the content of local SDEA and other PV agreements conforms to company standards per Q-15-01-018 and local requirements.
  • Submits all local SDE Agreements to GPV, Quality Systems, Contracts, and Training Operations (QSCTO) for review prior to finalization.
  • Submits all local Service and SDEA Agreements to GPV for review prior to finalization, in the event these agreements contain variations from the PV Agreement Language templates.
  • Responsible for requesting or providing a copy of all adverse event files for local product acquisition and divestitures.
  • Submits all approved local SDEAs and other PV Agreements to GPV QSCTO for central tracking within thirty (30) days of contract approval.
  • Report any changes to local PV agreements within thirty (30) days such as but not limited to changes in contact information or terminations of PV agreements.
  • Responsible for maintaining a list of all local SDEAs and other PV agreements including each product list and current status.
  • Ensures a local tracking system is in place, to monitor compliance to local safety data exchange timeframes.
  • At a minimum annually, the local affiliate will be responsible to reconcile their local SDEAs and other PV agreements against the list provided by GPV QSCTO of all current SDEAs and other PV agreements in the SDE database for their territory.
  • Training:
  • Maintains a version-controlled training matrix/plan for local PV personnel which includes but is not limited to Local SOPs, Local Regulations and references to the Global Affiliate PV Modules in ISOtrain.
  • Ensures training compliance with Global and Local PV training requirements in ISOtrain and other mandatory training as required by GPV AVE.
  • Ensures training of Affiliate personnel on relevant PV responsibilities is undertaken on at least an annual basis; that appropriate training records are maintained and compliance metrics related to this training is reported to GPV QSCTO.
  • Ensures that any training of partner company staff is completed according
  • to local contract requirements, and appropriately documented.
  • Audits and Inspections:
  • Acts as the key Affiliate contact for both internal audits and Regulatory Authority inspections.
  • Ensures that any Regulatory Authority communications are forwarded to the required GPV personnel and that any corrective actions are completed according to schedule.
  • Risk management (RM):
  • Is a member of the Affiliate Risk Management Team per Q-15-01-008-W004.
  • Reviews all Risk Management Plans and PSURs to obtain information on the risk/benefit profile of products.
  • Safety monitoring:
  • Monitors the risk/ benefits profile of local products and communicates changes or concerns to Global Pharmacovigilance (PV) and the Qualified Person Responsible for Pharmacovigilance (QPPV) (if applicable) for evaluation.
  • 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 hours contacts.
  • Business Continuity:
  • 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 Pharmacovigilance. 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 pharmacovigilance in particular including back-up systems for urgent exchange of information within an organization, amongst organizations sharing pharmacovigilance tasks as well as between marketing authorization holders and competent authorities.

Accountability

  • Achieving deadlines.
  • Maintaining budget.
  • Adequate and accurate reporting and administration.
  • Delegate tasks to junior staff.
  • Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures and accepted standards of best practice.
  • Generating and following company SOPs, policies and procedures / local regulations.

Administrative tasks

  • Receiving and filing incoming letters, documents.
  • Copying, folding, keeping track on departmental documentation.
  • Create, control, and monitor all administrative requirements of the department.

KEY INTERFACES:

  • Affiliate and Region medical, regulatory and pharmacovigilance personnel: Clinical Research Manager, Clinical Operations Manager, MedicalAdvisers; Medical Information team / specialists; Affiliate Regulatory Affairs; Scientific Project Managers; QA Dedicated Person; Affiliate Vigilance Expert; Global Pharmacovigilance.
  • Marketing and Sales of assigned product and therapeutic area; Market access teams
  • Affiliate Government Affairs; Affiliate Public Affairs
  • Global Medical Information; Global HEOR
  • Library Information Resources
  • International Medical Development / Global Project Team (GPT) / GSMS (Global Strategic Marketingand Services) personnel
  • Affiliate finance and Legal groups
  • Healthcare personnel, Investigators, Opinion Leaders
  • Institutions and Scientific or Medical Societies
  • Hospitals and Local Regulatory Authorities

AUTHORITY AND REPORTING LINES:

  • This position reports into the Medical Manager of AbbVie ADRIA & Croatia.

IDEAL CANDIDATE CRITERIA:

  • Medical Degree or Bachelor’s degree in a scientific discipline or higher
  • Experience working in a pharmaceutical industry and general knowledge on drug development and clinical research an advantage
  • Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general
  • Excellent verbal and written communication skills including strong presentation skills
  • High customer orientation
  • Excellent skills to set stake-holders relationship, networking, tact and diplomacy
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
  • Proficiency in English
  • Willingness to travel

CAREER DEVELOPMENT:

Possible career development roles:

•Head of Affiliate Medical

•ADRIA or Area Medical Adviser

•Clinical development, GPRD

•GPV

TECHNICAL COMPETENCIES:

•Management Skills

•Communication Skills

•Compliance & Process Improvement Skills

•Problem/Conflict Solving Ability

•Priority Setting

REQUIRED CORE COMPETENCIES / ATTRIBUTES:

Competencies Links to job responsibilities

ADAPABILITY

•Responds to changes in the business and clinical practice within thecountry; considers theimpact of these changes on the assigned product(s) and therapeutic area(s) and recommends ways to take advantage of new opportunities or counter threats to the business.

INITIATIVE

•Develops awareness and understanding of competitor issues/intelligence and communicates this information, whereappropriate, within the affiliate.

•Applies therapeutic area knowledge to recommend clinical studies and other medical projects that will strengthen the position of assignedproduct(s).

INNOVATION

•Helps develop Affiliate strategy by identifying future opportunities for the assigned product(s) and therapeutic areas(s) and works with HQ,Area and Affiliate colleagues to take advantage of those opportunities.

INTEGRITY

•Ensures that all activities and interactions are conducted in accordance with all applicable local,global and national laws, regulations, guidelines, codes of conduct, company policies and acceptedstandardsof best practice.

TEAMWORK &COLLABORATION

•Actively participates in Affiliate Brand teams, and helps develop Affiliate strategy in coordination with key stakeholders in the affiliate and Area HQ as appropriate.

•Supports sales/marketing/internal Affiliate teams to develop their scientific and technical expertise.

•Participates in the selection process to identify appropriately qualifiedphysicians the Company would wish to engage in collaborative efforts.

TechnicalCompetencies Links to job responsibilities

THERAPEUTIC AREA EXPERTISE

•Maintains an up-to-date scientific knowledge of assigned product(s) uses and key external data; develops core medical/scientific dossiers.

•Provides scientific support for, and helps maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the assigned products and areas of therapeutic responsibility.

•Supports sales/marketing/internal Area teams to develop their scientific and technical expertise through the delivery of scientific update presentations, and periodic training as required.

MANAGEMENT SKILLS

•Uses resources effectively and efficiently.

•Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.

•Maintain and operate within budget.

•Capable of analyzing and investigating issues and problem solving.

COMMUNICATION SKILLS

•Effectively practices listening skills before responding to issues.

•Effectively writes, presents and communicates information to internal and external clients, including divisional management.

•Effective negotiation skills.

COMPLIANCE & PROCESS IMPROVEMENT SKILLS

•Demonstrates good judgment on compliance issues.

•Ensure compliance with all applicable national laws and regulations, guidelines, codes of conduct, AbbVie’s policies and procedures and accepted standards of best practice

PROBLEM /CONFLICT SOLVING

•Able to analyze situations and conflicts without pre-judgments and assumptions

•Listens carefully and with an open mind

•Provides direct, complete, corrective and actionable feedback

•Reads situations quickly

PRIORITY SETTING

•Prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization.

•Quickly senses what will help or hinder accomplishing a goal

•Eliminates roadblocks

LOCATION:

•Based in Sarajevo, Bosnia & Herzegovina

SIGNATURES:

______

Employee Name Manager’s Name

______

Employee Signature Manager’s Signature

______

Date Date

1 | Page