JUST ONE, on behalf of its client, a very well-known Biopharma company, is looking for a:
Pharmacovigilance (PV) & deputy Regulatory Affairs Specialist
The company is designed to fully replace biopharma, OTC and medical device multinationals’ subsidiaries or business units in those countries, or therapeutic areas of CEE, Greece, Cyprus & Malta, that the multinational chooses not to enter, or to exit.
The company is staffed by a unique group of access-savvy managers and medical professionals who are dedicated to bring modern medicines to the people of above region. We are a service-oriented, high quality and ethically driven company.
The company is looking for enthusiastic, well organized, and goal-oriented person to join as Pharmacovigilance (PV) & deputy Regulatory Affairs Specialist, to provide medical leadership, insight and strategy and its Partners' medical and cross-functional teams on local and international level.
Responsibilities:
Act as local pharmacovigilance materiovigilance, cosmetovigilance (hereinafter collectively pharmacovigilance (PV)) responsible person towards the relevant local Health Authority (HA).
Monitor national legislation, HA guides and complies with regional/local legislation and company’s and/or its Partners’ requirements.
Ensure screening of local scientific literature, maintain/up-date screened local journal list.
Ensure proper collection, tracking, duplicate checking, accurate translation with quality control and retention of safety data.
Manage timely reconciliation of safety information with internal stakeholders
Liaise with the Country General Manager and other business units to ensure PV processes are in place on local level (e.g. to provide input and review local contracts).
Ensure local implementation of additional risk minimization measures/materials
Provide input and/or create local Pharmacovigilance System Master File
Gain HA approval for special cases e.g. early/expanded access programs
Ensure implementation of agreed urgent safety measures.
Assist maintenance of Company’s relevant procedural documents and execute accordingly.
Liaise with local HA, the company and Partners’ relevant functions, by serving as contact point as task requires.
Serve as local contact point for relevant internal and/or Partners’ PV audits, HA inspections,
Obtain and maintain access to required submission platforms, tools and databases and ensure proper use of those.
Drive regulatory processes in line with business objectives
Ensure proper translation and quality check of product information in a timely manner.
Support packaging material development.
Review promotional and non-promotional materials
Requirements:
University degree preferably in Medicine, Pharmacy or Life Sciences (biology, biochemistry, chemistry).
+2Y Experience in PV/ regulatory / medical / clinical experience
Familiarity with industry standards, codes and understanding of compliance considerations and demonstrate ability to work compliantly in a field-based role, within the medical organization.
High level of professionalism, ability and willingness to work effectively with multiple products, projects and partners in cross-functional team setting.
Excellent communication (verbal and written), presentation, and interpersonal skills.
Fluent in English.
To apply, please upload your CV here: https://www.justone.gr/cv -> Reference Job Offer ''PV''