Our client is an internationally active, well established, further growing Austrian pharma SME with an Rx portfolio in various indication areas including ophthalmology, ICU, CV, and some OTC products. The company is searching now for the management of the post-marketing PV/safety responsibilities of the group an internationally experienced EU-QPPV based in Czechia, Slovakia, Austria, or eventually another EU country.
Responsibilities:
- Key functions are the formal EU-QPPV & Head of PV Management roles with responsibility for a small team of local PV managers and as the contact person to local external PV partners and authorities
- Responsibilities according to Regulation (EC) No 726/2004 Articles 23ff including the establishment and maintenance of the PV system (incl, rRMMs), the preparation of PV reports as defined by regulations, answering requests from health authorities, and providing health authorities with any other information relevant to product safety
- Representation of the group at audits, inspections, and response processes to any relevant post-marketing PV matters, acting as point of contact for the regulatory authorities on a 24-hour basis and as the contact point for PV inspections
- Expediting ICSR reporting and aggregate reports (PSURs, RMPs, PASS studies …) in relation to quality, focusing on accuracy, completeness, and timeliness
- Safety databases management, training of personnel in relation to PV
- Ensure together with RA the appropriate medical input to PV reports including ICSRs and PSURs as well as for the registration documents, providing the safety contribution to regulatory authority submissions
- Management of (potential) AEs including the corresponding monitoring of the relevant literature in cooperation with local PV managers and external partners respectively
- Safety assessments and drug safety reports for signals or other issues, e.g. product quality, or in response to health authority (HA) requests
- Based on individual experience and qualification additional support as MA Manager for matters such as approval of marketing material, medical literature analysis/input for marketing et al and as MIO
Requirements:
- MD preferred or advanced science degree in Life Sciences is required
- High level of experience and expertise in PV in the EU, including aspects of medical safety, ideally also as EU-QPPV or deputy EU-QPPV
- Excellent knowledge of European regulatory requirements relating to PV
- PV systems experience (covering compliance, databases, procedures, QA, training)
- Experience with audits/inspections
- Fluent English proficiency (C2), further EU language skills are an advantage
- Highly reliable, communicative, entrepreneurial personality who is motivated to develop the PV system and stringently manage strategy and operation of all safety related tasks, issues, documentation, and reporting for a dynamic, internationally active pharma SME with flat hierarchies
The Offer:
The company offers a fixed monthly gross salary at a minimum of EUR 5.000,-- with possible overpay depending on qualification, experience, and local standards and besides the regular respectively defined EU-QPPV post-marketing tasks an interesting role with the opportunity to participate as part of the HQ management team also actively in the strategic development of the company.
Please send your application including CV and motivation letter under Kennnummer 104 105 preferably on our application portal ISG-Karriereportal or per eMail to bewerbung.seligo@isg.com.
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