About

• Job Description
• Area Safety Lead, Local PV, Australia/New Zealand
• This position reports into Area Safety Head and is based at Sydney, Australia
• POSITION SUMMARY: The Area Safety Lead is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
• This role will act as the Local Operating Company (LOC)’s and assigned territories (as applicable) main point of contact for pharmacovigilance matters with the local health authority.
• They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

PRINCIPAL RESPONSIBILITIES

• List major responsibilities and duties of the position, including delegated duties. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results.
• (TYPE BELOW THIS LINE)

• % OF TIME
• (Applicability and % of time will differ depending on the set up in the country)

• 1- Act as Local Nominated Person (including back-up nominated person)
• Function as nationally nominated person for Pharmacovigilance in Australia and New Zealand countries assuming the Pharmacovigilance as defined by national law. Local Nominated Person and their designated backups must ensure 24/7 availability within the countries where they are nominated in, if required by national law.
• Collaborate with the QPPV offices as required.

• 2- Oversight of the PV System & Overall responsibilities
• · Provide oversight of vendor resources in the countries in scope.
• · Managing and coaching of the direct reports if applicable.
• · Act as a delegate for the Area Safety Head, when required.
• · Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• · Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable.

• 20%

• 3- Safety Management & Reporting
• · Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
• · Maintain oversight on day-to-day adverse Drug Reaction events inbound and outbound reporting as applicable in the given territory.
• · Responds to safety-related health authority queries in the territory.
• · Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• · Maintain oversight of proper identification of local literature articles for AE reporting as required.
• · Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• · Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.
• · Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• · Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities.
• · Perform document management and archiving as required.
• · Responsible for the provision of information to the global teams for local activities compliance with individual cases and periodic safety reporting, implementing of risk management plans, and key performance indicators related to overseeing local implementation of any other specific risk management activities.
• · Perform translation for ICSR and PV-related documents, as required.

• 40%

• 4- Collaboration & Support
• Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC.

• 15%

• 5- Procedural Document
• Maintain local procedures where applicable and assessing the impact of changes for the global procedure to local procedures.

• 5%

• 6- Audit & inspection readiness
• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.

• 5%

• 7- PV contract management
• Management of PV clauses to be included within local agreements.

• 10%

• 8- Business Continuity
• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).

• 5%

Other Duties

• Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the job. Enter “N/A” if no additional duties need to be listed.

• N/A

Qualifications

• Describe the minimum knowledge, skill, related experience, and ability requirements for the position.

Education

• Health care science professional (preferably Physician or Pharmacist)

Years of Related Experience

• 4-6 years of relevant experience.

Knowledge, Skills, Abilities

• Include any required computer skills, certifications, licenses, languages, etc.
• · Pharmaceutical industry experience including product vigilance responsibility role.
• · Ability to organize workflow activities and manage multiple critical issues.
• · Experience with vendor resource oversight.
• · Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• · Expert knowledge of global, regional, and local procedural documents as applicable.
• · Computer literate with knowledge of relevant IT safety systems.
• · Excellent verbal and written communication skills.
• · Ability to establish and maintain open relationships within the organization and with authorities.
• · Demonstrable knowledge of all local requirements and of global aspects of product safety.
• · Fluency in the national language(s) and the English language.