Product Services Coordinator – GMAIST

  Pharmacovigilance

Job title: Product Services Coordinator – GMAIST

Company: Pfizer

Job description: Position Summary:

The Clopine coordinator role is responsible for providing key support to healthcare professionals across Australia and New Zealand prescribing and dispensing and utilizing ClopineCENTRAL database. This exciting role focuses on ensuring protocol compliance, quality of service and data integrity by continous interaction with Clopine HCP’s.

Comfortable working autonomously, you will enjoy customer facing interactions including clinicians and pharmacists located across different states in ANZ. This role directly reports to Senior Medical Manager, GMAIST, HBU.

You will be responsible for maintaining daily functionalities of service for registry and provide after hours support where needed by working in collaboration with the Senior Medical Manager and the services Team to ensure activities are effectively executed

You will also contribute to overall safe use of anti-psycotic by ensuring timely reporting and follow up of adverse events. While doing so you will uphold Pfizer Australia’s commitment to high standards of conduct in all its dealings with the medical profession.

Capacity for strategic thinking, along with excellent interpersonal, communication and negotiation skills, complemented by problem solving abilities and a flexible approach are essential for success in this role.

Responsibilities:

Managing Clopine Registry Database

  • Respond to telephone, fax and email enquiries in a timely manner and in compliance with corporate policies
  • Registration of patients, personnel and Centres/Clinic within the registry
  • Ensure performance of the database, validity of data entered and completion of all required day to day processing
  • Maintenance of registry website and identifying issues
  • To assist in switching patients (usually higher in number) from other brands in Australia/New Zealand as per the requirement by the commercial team.
  • Additional material orders requested via Australian HCP by liaising with the Pfizer Sales force to provide timely and quality services
  • Completion of new weekly tracker
  • Non-exclusive tasks and new areas can arise based on patient and HCP management that would need to be addressed.
  • The colleague would support the manager in generation of weekly/monthly reports and dashboard management
  • The colleague would be responsible in assisting the training for new hires and in the completion of onboarding activities for new hires
  • The executive would be supporting in stakeholder management like BT validation and testing support for any new changes to be applied, developed and implemented in the system
  • Providing additional support to the manager in terms of preparation of supporting documentation for any new processes or already existing process within the registry
  • The colleague would be responsible in supporting the transition of Clopine center in different states of Australia on a priority basis in terms of ClopineCentral related activities

Reporting and Data / Policies Management

  • Adverse Event reporting of additional fields and areas identified to meet compliance requirements. Identified via various sources like calls, emails and faxes.
  • Adverse Event reporting within required regulatory timelines and in accordance with corporate policies
  • Completing and reviewing of all mandatory corporate policies, training modules and procedures within allocated timeframes
  • Identifying and tracking the patients with overdue blood test results and blood test delays and extension to be reported. Follow-up for overdue patients via calls/emails actively.
  • Protocol updates to align with the current prescribing information and related additional tasks and follow-up actions required.

Training and Communication

  • Training internal and external stakeholders on the database
  • Aid in the coordination of sales and marketing initiatives for the registry
  • Actively communicate any process/impacted changes to Healthcare professionals via various means and regular and follow-up training sessions to be conducted to help them adapt with the new process and changes
  • Support the review and alignment of database with global standard monitoring system in terms of monitoring requirements and eliminating fields that are with potential customer impact. The team plays a crucial role in the process by minimizing any customer impact by providing adequate support and training to HCP’s via call and emails. Manage the transition for customers by communicating the need and purpose of registry as a regulatory commitment for monitoring hematological parameters.

Change Management

  • Identification and reporting of additional fields and information requests in the required format along with the patient History within stipulated compliance timelines
  • Adopting strategies and notified process changes in order to comply with the reporting requirements
  • Aligning the communication materials like protocol in line with the prescribing information to mitigate any risk of safety and quality concerns.

On Call Services & Query Resolution

  • Provide assistance for the on-call services to customers after hours when required.
  • Address and manage the urgent customer enquiries after hours and on weekends including timely resolution.
  • Identify needs and requirements of internal and external customers and providing necessary resources, service and advice
  • Assist in the maintenance of appropriate documents such as protocols and monitoring user feedback
  • Generating adhoc data/reports for external clients for research and management purposes where appropriate.

REQUIRED SKILL SET

  • Technical : Understanding of post-marketing safety surveillance
  • Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
  • Analytic skills. Ability to examine data, formulates reasonable hypotheses, and design and execute analyses to test them. Analytical and critical thinker
  • Communication skills. Excellent communication/interpersonal skills – both written and verbal (particularly dealing with telephone enquiries)
  • Personal skills. Strong organizational skills and ability to prioritize multiple projects and meet deadlines. Has a strong and sincere customer orientation with emphasis on patient care. Adopts corrective action as a work ethic. Possesses high levels of discretion and diplomacy. Possesses a strong initiative instinct and ability to function independently. Should also be a team player demonstrating collaborative skills and adaptability to different situations. Must be able to work well under pressure and demonstrate the desired skills at all times. Ability to learn and adapt to new situations. Comfortable working within strict time frames and able to prioritize in order to meet deadlines.
  • Must be flexible enough to work with different time zones. Willing to work in shifts as and when needed.
  • Interpersonal skills. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Assertive and able to work with initiative.
  • Regulatory knowledge: Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data
  • Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred

Education:

  • Degree in Pharmaceutical Sciences (Masters preferred)
  • Registered Nurse or similar
  • Other Allied Health Qualifications will also be considered Experience:
  • Minimum 1-2 years of experience in
  • Medical Information Services/Medical Affairs
  • Pharmacovigilance/Drug Safety
  • Medical and Scientific writing, experience in using search tools, developing search strings, and assessing search results
  • Case processing, medical coding and writing medically related safety narrative of the cases.
  • Literature search and secondary research – experience in conducting specific search strategies and retrieving relevant articles from public domain. (technical/analytical skills)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

#LI-PFE

Expected salary:

Location: Mumbai, Maharashtra

Job date: Sun, 12 Jun 2022 03:57:18 GMT

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