Auftragsdetails

The EU Qualified Person is responsible for Pharmacovigilance (EU QPPV, throughout the document ‘QPPV’) according to the European PV Regulations and guidelines for a customer who is a Marketing Authorization Holder (MAH) in EU. The QPPV is responsible for the safety of the medicinal product(s) and for the compliance with the pharmacovigilance guidelines.

Essential Functions Include:

General

• Ensure back up procedures in case of absence of the QPPV shall be in place and QPPV should ensure the deputy QPPV has all the necessary information to fulfil the role.

Establishment and maintenance of the PV system

• Ensure, with the MAH, the establishment, maintenance and performance of a pharmacovigilance system that includes the information about all suspected adverse reactions collected and collated to be accessible at least at one point within the EU.
• Having access to the Pharmacovigilance System master file (PSMF) and being in a position of authority to/ensure and verify that the information contained in the Pharmacovigilance System Master File (PSMF) is an accurate and up to date reflection for the pharmacovigilance system under the QPPV’s responsibility.
• Oversight of any emerging safety concerns and any other information relating to the benefit-risk evaluation of the medicinal products. Act as a single pharmacovigilance contact point for the competent authorities in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals). Making inputs to the preparation of regulatory action in response to emerging safety concerns.
• Having an overview of all ongoing and completed clinical trials and other studies the marketing authorization holder is aware of and which may be relevant to the safety of the medicinal products
• Having an overview of sources of information for instance with whom the marketing authorization holder has a contractual agreement.
• Having an overview of all procedures relevant to pharmacovigilance in place at every level at the marketing authorization holder to ensure consistency and compliance across the organization.
• Involvement in the preparation of contractual arrangements when new partners are established and ensure all necessary provisions to the pharmacovigilance system are included.
• Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitment relating to safety or the safe use of the products. Providing input into the preparation of regulatory action in response to the competent authorities in Member States and the Agency.
• Being aware of and having sufficient authority over the content of risk management plans. Making inputs to the risk management plans.
• Having awareness of risk minimization measures.
• Being involved in the review and sign-off of protocol of post-authorization safety studies (PASS) conducted in the EU or pursuant to a risk management plans agreed in the EU. Having awareness of post-authorization safety studies requested by a competent authority including the results of such studies.
• Ensure conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP. Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities in Member States and the Agency.
• Ensure a full and prompt response to any request from the competent authorities in Member States and from the Agency for the provision of additional information necessary for the benefit risk evaluation of a medicinal product. Providing input to the benefit risk evaluation and any other information relevant to the benefit–risk evaluation to the competent authorities in Member States and Agency.
• In some cases, delegating specific tasks, under supervision to appropriately and qualified trained individuals and ensuring these are documented.

PV system performance

• Having oversight over the functioning of the system in all relevant aspects, including its quality system (e.g., standard operating procedures, contractual agreements, database operations, compliance data regarding quality, completeness, and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance).
• Influence the performance of the quality system and the PV activities of the MAH and ensure implementation of changes to the PV system.    
• Review compliance data on a regular basis (e.g., on risk management commitments and post authorization safety systems).

Quality system (procedural documents, document and record control, training, auditing)

• Review outcome of any reviews of the quality system.
• Review audit schedules and corrective and preventative action plans following audits that are relevant to the PV system and assure that appropriate corrective actions are implemented. Requests for PV audits to be conducted either routinely or for compliance, including audits of licensing partners.
• Maintain all documentation (including trainings) according to the applicable Document and Record control procedures.
• Participate in relevant meetings with the MAH to fulfil the responsibilities outlines above e.g., Global PV meetings, Compliance Meetings, Crisis Management Team Meetings as appropriate.

Computerized system and databases

• Having awareness of the validation status of the database, including any failures that occur, and significant changes that are made to the database.

Qualified candidates must have:

• University Degree (BSc, EQF level 6), and/or Higher professional training (MSc or PhD, EQF level 7 and 8) in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, nursing, life science, medical technology or biology.
• General medical knowledge Note: if not completed basic medical training (in accordance with Article 24 of directive 2005/36/EC) then must have access to a medically qualified person (MAH or ProPharma Group).
• Ideally expertise (or alternatively access to expertise) in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics.
• Documented experience in all aspects of PV for a period of five years and experience should be commensurate with the size/complexity of position.
• Theoretical and practical knowledge in PV systems including experience with different MAHs/ PV systems.
• Good knowledge of EU PV legislation and guidance.
• Sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorization holder.
• Understanding and awareness of related legislation, as well as knowledge about and exposure to PV systems.
• Leadership and Authoritative presence.
• Ability to influence at senior levels of an organization.
• Managing, organizing and changing processes/systems.
• Candidates must have fluent communication skills in Swedish. Knowledge in other Nordic language skills will be a plus.

• We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***