Pharmacovigilance Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Essential Duties and Responsibilities:

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

Responsible for activities described below, in the assigned territory - Malaysia, Indonesia, Singapore and Brunei.

Local QPPV Role

• In the capacity of Local QPPV (Local Qualified Person Responsible for Pharmacovigilance), have an oversight of all pharmacovigilance activities in the territory per applicable local legislation.
• Act as the local contact point with authorities for PV related matters and register as local contact point with authorities in Singapore and Malaysia, per local regulations.

Responsible Person for PV Malaysia (RPPV) Per Local Regulations

This role is appointed as RPPV for Malaysia by Vantive as PRH (Product Registration Holder). The RPPV is responsible, per local Malaysia regulations for the following:

• To establish an effective system for monitoring ADRs (adverse drug reactions)/ AEFIs (adverse events from immunization) associated with the use of products registered under the PRH.
• To ensure that information pertaining to ADRs which come to the knowledge of the PRH, including through medical representatives, is collected, and collated so that it is accessible at a single point.
• To ensure that all local ADR reports are submitted to the Authority in a timely manner as per the required regulatory timelines.
• To submit all relevant safety information such as Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Reports (PBRER), post-registration study reports and risk management plans (RMP).
• To ensure all risk minimization plans (e.g., Direct Healthcare Professional Communication {DHPC} letter, patient guide etc.) have been carried out, per local regulations.
• To ensure that any request for additional benefit-risk information by the Authority is answered fully and promptly, including sales data of the product(s) concerned.
• To alert the Authority of any emerging safety issue(s) involving products registered under the PRH.
• To ensure submission and management of Pharmacovigilance System Master File (PSMF) and Pharmacovigilance System Summary (PVSS) is done accordingly as required by the Authority for the PRH under his or her responsibility.
• Shall act as the single PV contact point for the Authority, which is contactable whenever needed.
• Shall attend and be responsible for Good Pharmacovigilance Practices Inspections (GVPI) by authorities.

Safety Risk Management Activities

• Identify the local regulatory requirements for RMP (Risk Management Plan) submissions, communicate the requirements to the Global team and provide local inputs as required.
• Implementing risk minimization measures locally as appropriate.
• Identify, escalate, and communicate all relevant local critical safety issues/ signals.
• Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures.
• Maintain an overview of the safety profiles of medicinal products, of any emerging safety concern or other information relating to evaluation of the benefit-risk of medicinal products for which Vantive holds a marketing authorization in SEA.

Pharmacovigilance Quality Systems

• Have a thorough understanding of and comply with the Vantive Pharmacovigilance Quality system and policies.
• Maintain expert knowledge and awareness of local pharmacovigilance regulations and implement as appropriate.
• Ensure adequate understanding of audit and inspection preparation and readiness.
• Ensure understanding of the CAPA (Corrective and Preventive Actions) process.
• Responsible for performing CAPA activities per identified roles.
• Ensure compliance with procedures for document management retention and archiving.
• Understand and implement the document change management process and act as SME (Subject Matter Expert) for local procedures.
• Ensure all training requirements for the role are met.
• Identify appropriate stakeholders and ensure they are trained in PV reporting requirements/procedures.
• Build alignment and collaboration with local Regulatory Affairs, Medical Affairs, clinical Operations, Quality Assurance, and Business Unit teams.
• Effectively communicate all relevant safety information and compliance concerns with the Asia Pacific Regional PV.
• Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan).
• With regards to third party agreements:

• Perform due diligence and ensure the appropriate PV / safety requirements are incorporated into the agreements.
• Perform regular review of the agreements to ensure safety requirements are aligned to the current regulatory requirements and perform reconciliation of data between the third party and Vantive.
• Have responsibility for the oversight of safety signals for agreements where the third party is the MAH (Market Authorization Holder).

Vantive Pharmacovigilance Signal Management

• At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician.
• Collection of as much AE case information as possible.
• Escalation of requests received directly (by local PV contact) or indirectly (by country RA/ Country QA) from Regulatory Authorities relating to product safety, efficacy and quality.

Case Intake

• Manage the receipt and capture process for adverse events (AE) and other safety information report collection in the Pharmacovigilance safety database.
• Various sources of AE include but are not limited to; spontaneously reported cases from patients, healthcare professionals (HCPs), nurses, Vantive employees (Including AEs associated with product complaints and AEs associated with medical queries), social media reports, partner companies and regulatory authorities; and solicited cases from Patient Support Programs (PSP), Market Research Programs (MRP), clinical studies and call centers.
• Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.
• Perform the initial assessment on the case validity, check for core case elements. Perform duplicate checks and request for case deletion as required.
• Perform a seriousness assessment and assess expectedness against the local label.
• Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database.
• Determine the requirements for follow up information and manage the process for collection and handling queries from the Global team.
• Reassess the follow up information in the context of case validity, seriousness and expectedness; capture all follows up information and source documents in the Pharmacovigilance safety database.
• Perform ongoing tracking and local quality check and AE cases for follow ups and submission requirements.
• Manage patient identified batch review requests as required.
• Perform reconciliation activities for AE cases as required.

Regulatory Submissions

• Maintain expert knowledge of the regulatory reporting requirements and ensure the reporting rules in the system are aligned to the local reporting requirements.
• Manage the process for expedited submission of AEs to local authorities with translation of documents as required.
• Track submissions in the Pharmacovigilance safety database and archive all submission records.
• Respond to submission related queries from the local regulatory authorities and archive all regulatory related correspondence.

Other Responsibilities

• Provide the appropriate local inputs for the PSMF (Pharmacovigilance System Master File) sections.
• Understand any specific local regulatory report requirements (e.g., AE line listing), request the required information from the Global team and submit the reports to authorities as per regulatory requirements.
• Ensure all obligations are met as per Safety Data Exchange Agreements (SDEA) with business partners.
• Escalation of requests received directly (by local PV contact) or indirectly (by Country RA /Country QA) from Regulatory Authorities relating to product safety, efficacy and quality to be disseminated to Manager SEA, Head Asia Pacific (APAC) PV and other stakeholders as per Vantive procedural requirements.

Qualifications:

• Strong analytical, problem-solving skills.
• Fluent in verbal and written communication in English and Bahasa.
• Strong interpersonal skills and should be able to work in an inter-country and virtual environment.
• Ability to work under tight timelines and changing priorities with some supervision and attention to details.
• Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
• It is preferred the RPVV for Malaysia is based in Malaysia.

Education and/or Experience:

• Bachelor’s degree in pharmacy, nursing, or medical science or an equivalent degree in a scientific field.
• A minimum of 1 year of experience in pharmaceutical industry (any stream). Direct PV experience would be preferred.
• Should be medically qualified or will have access to a medical qualified person at Vantive.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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