Quality Assurance and Market Access Manager

Medical Valley / Apotekarjobb / Vellinge
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Medical Valley is a Swedish start-up company operating in the generic pharmaceutical market with a 100% focus on the Nordic region. The offices are located in Höllviken, Sweden. Medical Valley is partly owned by an international pharmaceutical group with its own production sites. Medical Valley has recently initiated commercial activity to all Pharmacies in Sweden, Denmark and Norway and is expected to reach a turnover of around 30mkr in 2015. During 2016 Medical Valley plans for significant expansion with and expanding product portfolio and new territories.

Role:
To act as the company Quality Person, "Sakkunnig," towards health authorities. To assume operational responsibility of the quality, pharmacovigilance and regulatory affairs requirements of the company. To actively assist in detecting and exploring product and market opportunities for the company. To ensure that the documents describing the Quality and Pharmacovigilance system are in place and subject to document control in relation to their creation, revision, approval and implementation. To act as medical information service to health care professionals and patients. To collaborate with the Pharmacovigilance System Provider, and, if appropriate, act as Local QPPV. Key tasks and responsibilities: Administration of the Quality System, including to Create/Train/Maintain SOPs within QMS. Administration of Pharmacovigilance System. Administration of local Regulatory Affairs - submissions and variations. Coordination with other departments and/or business partners - PV provider, Regulatory Affairs, Quality Affairs, Medical Department etc. Collaboration in the reception and triage of Adverse Drug Reactions, Product Quality Complains, and/or Medical Inquiries. To assist in detecting and interpreting new product opportunities by identifying niche products in terms of competition, patent situations, reimbursements, substitutions or other market critical information.

Requirements:
A degree in Pharmacy / Pharmaceutical competence. Min. 1 year experience in working with quality assurance, and/or pharmacovigilance and/or regulatory affairs. Experience in communicating with health authorities. Strong operational business skills and desire to grow with the company. Fluency in Swedish and English - desired Danish / Norwegian / Spanish

Varaktighet, arbetstid
Tillsvidare
Heltid

Publiceringsdatum
2015-08-21

Tillträde
Snarast

Ersättning
Fast månads- vecko- eller timlön

Så ansöker du
Please send you application via e-mail to tomas@medicalvalley.se with name and "Quality assurance" in the theme row. Interviews will be conducted on a continuous basis
Ansökan kan skickas till e-postadress: tomas@medicalvalley.se

Kontakt
Tomas Henderup 0703-666491 tomas@medicalvalley.se

Företag
Medical Valley

Adress
Medical Valley
23632 HÖLLVIKEN

Kontorsadress
Brädgårdsvägen 28

Övriga kontaktuppgifter
Telefonnummer: 0703-666491
E-postadress: tomas@medicalvalley.se

Jobbnummer
2399592

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