Pharmacovigilance Agreements Lead

Swedish Orphan Biovitrum AB (publ) / Biomedicinjobb / Stockholm
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Do you want to be part of Sobi where we are transforming the lives of people affected by rare disease? Do you want to Lead the management of Pharmacovigilance Agreements (PVA's) from development to implementation in accordance with relevant procedures?
We are now looking for a Pharmacovigilance Agreements Lead to coordinate development, implementation and compliance monitoring of PVA's.
Key Responsibilities
Contribute to receipt, tracking, monitoring and documentation of all PVAs
Accountable for ensuring quality, review, compliance and accuracy of all PVAs
Responsible for coordinating activities related to PVAs and ensuring cross functional input to new and existing PVAs
Contribute to development of PVA processes and PVA template(s)
Responsible for communication of contractual commitments to concerned Stakeholders when a PVA becomes effective
Responsible for maintenance of the PV agreements teams site
Provide PVA subject matter expertise during audits and inspections
Qualifications
University level qualification in biosciences or healthcare
At least 3 years' experience post-graduation in the pharmaceutical industry
Skills & Personal Attributes
Thorough knowledge of regulatory requirements, specially within the European Union
Computer Literate
Fluent in English
Knowledge of following types of agreements: Sales, Commercial, Market Research, Patient Support Programmes, Post Authorisation Non-Interventional programmes / studies, Investigator Sponsored Studies
Strong interpersonal and communication skills
Able to work effectively both independently and collaboratively across the organization
Delivery focus (take initiative and undertake tasks through to completion)
Demonstrated problem solving skills (including taking ownership to ensure timely resolution) with delivery focus and the ability to successfully execute in an environment under time and resource pressures whilst maintaining resilience
Good attention to detail with high quality written outputs, with good organizational abilities (able to establish priorities, schedule activities and meet deadlines) prioritization, and time management proficiencies.
Location: The position will be based in Stockholm, Tomtebodavägen 23 A Solna
Reporting to: Helena Petersen, Drug Safety Operations
For more information: please contact Helena Petersen, helena.petersen@sobi.com
If you are interested in applying for this position, please submit your CV and cover letter using the link below

Publiceringsdatum
2019-11-11

Så ansöker du
Sista dag att ansöka är 2019-12-11
Klicka på denna länk för att göra din ansökan

Adress
Swedish Orphan Biovitrum AB (Publ)
Tomtebodavägen 23 A
17165 Solna

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Swedish Orphan Biovitrum AB (Publ) (org.nr 556038-9321)
Tomtebodavägen 23 A (visa karta)
171 65  SOLNA

Arbetsplats
Sobi

Jobbnummer
4950120

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