Job Description

The Senior PV Specialist (Affiliate) is accountable for the managing, maintenance, and continuous improvement of the Pharmacovigilance (PV) system for the company in the country (including legal entities under the company). To ensure adherence to established local and company Global processes and guidelines, adhering to national and international regulations and guidelines for pharmacovigilance.

The Senior PV Specialist is also responsible to lead and coordinate the PV team members in the country Core Responsibilities The Senior PV Specialist

• The Senior PV Specialist (Affiliate) is responsible to organize, implement, and maintain the Affiliate PV System.

After-Hours Availability

• Ensure after-hours availability if required by the local regulation.

ICSR handling

• Ensures that local processes, procedures, and systems are in place for Individual Case Safety
  Report (ICSR) management including receipt, documentation, forwarding to PSRM PVOperations, tracking, follow up etc.
• Ensure collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials)
• Ensure collection of safety data and other PV-related responsibilities in relation to organized data collection schemes including, non-interventional studies, registries, customer engagement programs (CEPs) etc.
• Ensures screening of The company-sponsored social media (web sites, web pages, blogs, vlogs, social networks, internet forums, chat rooms or health portals) for safety information.
• Ensures screening of local language medical or scientific literature, not included in PSRMglobal literature review.
• Ensures that patient confidentiality and privacy in accordance with local applicable laws and regulations are adhered to.
• Ensures handling of safety information

Periodic Safety Reporting

• lnforms Safety Systems Team (SST) about the requirement/ change in requirement of any Periodic Safety Update.
• Report (PSUR) in liaison with local regulatory affairs.
  Provides safety information required for preparation of periodic safety report, upon request to SST.

Compliance

• Ensures a local tracking system is in place, to ensure timely submissions of ICSRs to PV Operations.
• Monitors Affiliate PV system performance and compliance. Reports monthly compliance metrics to Global PSRM.
• Maintains awareness of local PV legislation and of relevant international legislation, regulations, and guidelines.
• Ensures tracking and communicating changes in local PV regulations that may have an impact on standards and procedures of Global PSRM.
• Maintains compliance with local agreements, including reconciliation and safety data exchange between partner companies.
• Completes monthly ICSR reconciliation with interacting functions and/or departments, including medical information, product complaints.
• Ensures functionality check of common PV mailboxes, phone numbers used for medical information/PV, and fax number.
• Ensures any changes to Affiliate PV personnel are communicated to the regulatory authority and relevant
• Global PSRM personnel in a timely fashion.
• Ensures local deviation procedure is in place to document necessarily planned departures from procedures and to be used when managing non-conformities.
• Arising from product complaints (in association with QA).

Training

• Maintains a version-controlled training matrix for local PV personnel.
• Ensures basic PV training of new Affiliate employees and refresher training at least annually and that appropriate training records are maintained.
• Ensures relevant training of new PV staff.
• Ensures training on and compliance to global and local SOPs, and relevant regulations and legislations.
• Ensures that any training of partner company staff is completed according to local contract requirements and appropriately documented.
• Creates PV training material where applicable and Approves PV Training material authored by others.

SOPs

• Ensure implementation of PSRM standards and procedures, as applicable.
• Ensures local processes and procedures are developed and implemented to define pharmacovigilance responsibilities in line with PSRM standards and procedures, as well as local regulations, as applicable.

Audits and Inspections

• Be the key Affiliate contact for both internal PV audits and regulatory authority PV inspections.
• Ensures that any regulatory authority communications are forwarded to the required PSRM personnel and that any corrective actions are completed according to schedule.

Safety Data Exchange (SDE) Agreements and other PV agreements

• Ensures a local process is in place for the management of local SDEAs and PV agreements that conform to the company Standards per global procedures and local requirements.
• Ensures that PV matters are appropriately considered during the selection of service providers and in the contractual arrangements when subcontracting PV activities.

Risk Management Plan

• Ensures local implementation and tracking of activities in accordance with Risk Management Plans (RMPs)

Safety inquiries

• Ensures handling of inquiries relating to product safety including regulatory authority inquiries.
• Informs Regional Leads concerning urgent safety restrictions.

Safety Signals

• Informs SST about any potential signal or safety concern identified at the local level.

PV business continuity

• Ensures the planning of PV business continuity and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.

Archiving

• Ensures record retention of all PV-related data and documents according to the company's Global requirements and national requirements.

Expires on 22 Jul 2022
Posted By Gerard James Rozario (Reg No: R21101884) Tel: +65 6738 6228 gerardj.rozario@peoplesearch.jobs

Requirements

• Minimum three years of working experience within the Pharmaceutical MNC and a minimum of two years within pharmacovigilance.
• Strong communicator. Excellent project management skills, excellent team working skills, excellent organizational skills, and capability of working efficiently in the local team as well as in other cross-functional teams. Able to operate internationally with fluent English.
• Proficiency in computer skills, as required.

Location : West, Singapore
Kindly indicate your current/last salary details and your notice period If the above speaks to you, we’d love to hear from you. Please send in your updated CV to gerardj.rozario@peoplesearch.jobs (Gerard James Rozario, Reg No: R21101884) if you feel there is a fit with your experience and interest. You may forward this great opportunity to someone who would be a great fit for this role. All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted. PeopleSearch Pte Ltd
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