Pharmacovigilance Specialist (LCPPV)
PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.
Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report.
This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.
- The responsibilities set forth in this document are neither project nor country specific; they apply across all local PV projects of PrimeVigilance (applicable to all LCPPVs and Deputy LCPPVs) worldwide. Therefore, this Job Description must be viewed in context with the respective project contractual agreement.
- Client/MAH specific arrangements, such as contact details for safety data and timelines, can be specified in a Safety Data Exchange Agreement (SDEA), other PV Agreement, Joint Operating Guideline (JOG), Project Plan, or a similar document.
- The tasks and responsibilities of the LCPPV Deputy are the same as those of the key LCPPV during the LCPPV’s unavailability (both planned and unexpected.) During other periods of time, the LCPPV Deputy is responsible for maintaining their skills, education, general and local PV knowledge, understanding of the local regulatory updates, project specific requirements for handling of safety information and product information. The LCPPV’s responsibilities include collecting and assessing safety information and regulatory intelligence through the performance of pharmacovigilance (PV) activities at the local (national) level, ensuring compliance with the applicable local regulations and requirements and acting as a point of contact for the local Regulatory Authorities (RA) with regards to PV
Related to Regulatory Authorities:
- Register with the local regulatory authority at the beginning of the project
- Act as the primary point of contact for the regulatory/health authority/authorities
- Monitor regulatory authority website weekly and keep abreast of changes to local PV/Regulatory legislation (e.g. Individual Case Safety Report (ICSR) reporting rules), as relevant to comply with the regional and national obligations. LCPPVs shall make every effort to obtain such information (i.e. sign-up to regulatory alerts/newsletters, monitor the web pages of RA on a regular basis, contact RA for further information).
- Forward the identified Regulatory updates/information to the Client and/or the appropriate Project Team at Primevigilance, as applicable
- Communicate to the Client, EU QPPV and PrimeVigilance Project Manager within the 1 working day any discussions with a regulatory authority, or any request from the RA. Ensure appropriate documentation of any communication.
- Support the Client with the local regulatory authority requests for information which may include: facilitation, translation, response review and meeting participation
- Assist with the submission of any PV related documents to the RA (Notification of LCPPV, aggregate reports, responses to safety enquires, etc.) upon request
- Provide support with the local implementation of risk minimization measures (e.g. identification of distributors for Direct Healthcare Professional Communication, assistance with the translation, revision and submission of local educational materials, etc.)
- Local management/oversight of risk minimisation measures, activities related to urgent safety restrictions and emerging safety issues, if applicable
- Assist with the submission of ICSRs to RA, if requested
Local Literature Screening (if applicable)
- Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information regarding Client’s medicinal products and those of the same class
- Provide English summary/translation of the detected literature articles (for all suspected ADRs and potentially relevant safety information)
- Provide Local Literature Screening tracker monthly to the Project Manage
Handling of Safety Information
- Forward any safety information, Adverse Event (AE), Product Quality Complaint (PQC) and Medical Information Enquiry (MIE) to the Client and/or the appropriate Project Team at Primevigilance, as applicable, obtained from any sources (including RAs) within the agreed timelines as defined in the applicable Client’s SOP, SDEA, PV Agreement, Project Plan, Note to File, JOG, etc.
- Assist with the attainment of follow-up safety information from healthcare professionals or consumers/patients, if additional urgent follow-up information and/or action on behalf of the Company may be required.
- Maintain an overview of detected AEs and safety information, PQCs and MIEs and assist with data reconciliation
- Communicate immediately any suspected or arising safety issue(s) in the concerned country(ies) to Primevigilance and the Client as per applicable procedures and communication channels including information about any issue of potential or actual media/public interest, information about any potential or actual legal action or liabilities pertaining to clinical safety associated with the MAH product(s)
- Ensure that the process on handling of personal data in pharmacovigilance documents is performed in accordance with the applicable regional and national regulations
- Provision and maintenance of documentation defining processes and local archiving
Audits and Inspections
- Support the Client and PrimeVigilance during Audits and Inspections, as required, including attendance, provision of requested documentation and completion of Quality Events/Corrective And Preventative Actions (CAPAs), if needed
Availability and Periods of Unavailability
- Be available to the Client, the Regulatory Authority and PrimeVigilance as required by the local guidelines, legislation/and/or project specific contracted conditions, and respond to communication from PrimeVigilance and/or the client within 1 working day.
- Inform of any absences, leave OOO message when applicable
- Ensure that a handover is performed and documented with the LCPPV Deputy before and after unavailability (planned and unplanned) and that the handover form is prepared and provided to the appropriate PrimeVigilance Project Team(s).
- Respond to telephone/email contact checks as per PVL-PVSOP-027 (Answering Telephone Calls and Conducting Contact Checks
Cooperation with PrimeVigilance and the Client
- Follow the country specific pharmacovigilance regulatory guidelines and legislation
- Operate according to controlled written procedures owned by PrimeVigilance and the Client
- Closely cooperate with and follow recommendations for action of PrimeVigilance and the Client
- Participate in PV trainings organised by PrimeVigilance and the Client, and to complete all training assignments within the defined timelines. Maintain up to date training file.
- Participate in meetings/teleconferences intended for LCPPVs (Deputy LCPPV only in absence of key LCPPV unless otherwise specified)
- Provide translation or revision of any PV related documentation upon request
- Ensure that local PV files are properly maintained as per applicable PrimeVigilance procedures, and that local security and data privacy requirements are met
- Provide monthly report (and local literature screening tracker, if applicable) on performed activities
- Respond to reconciliation requests
- Escalate detected deviations and ensures appropriate corrective and preventative action are put in place
- Populate any additional documentation (e.g. Due diligence questionnaires, etc.) and provide them to PrimeVigilance/Client upon request
Qualifications and Training
- LCPPV shall have good English and local language language skills (both spoken and written), PV training and/or working experience and other educational or professional background as required locally.
- Read and understand all procedures and processes when provided
- Complete the assigned trainings within the defined timelines
- Attend training, as requested and maintain personal training records
- Maintain up-to-date Curriculum Vitae and training records and provide them to PrimeVigilance and Clients upon their request
- Maintain Annual Training Plan in cooperation with PrimeVigilance for local PV related trainings and provide training certificates upon request
- Maintain required level of understanding of Client’s products and their safety profile
All your information will be kept confidential according to EEO guidelines.
- Work within a successful, highly qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company
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