Global Pharmacovigilance & Medical Info Manager

Do you have a strong background in Pharmacovigilance and knowledge within Medical Information and Regulatory Affairs? Sedana Medical is looking to hire a person to cover three different areas that are naturally related to each other. This is a great chance for you to join an expanding company and dedicated team!
Apply today as selection is ongoing and we will interview candidates continuously.
We look forward to receiving your application!

JOB DESCRIPTION
As Global Pharmacovigilance & Medical Info Manager you will have a key role at Sedana Medical providing your PV expertise to the organisation and supporting the areas of Medical information and Regulatory Affairs. You will report to the Medical Director, Clinical Training, Education & Patient Safety.

PHARMACOVIGILANCE
The main task is to manage the day-to-day operations within the PV department and liaise with the team and management to ensure an effective functioning. This role will be primarily responsible for the quality and compliance of all PV deliverables and be involved in training, business development, audits/inspections, and liaise with the external vendor/QPPV.

Other tasks and responsibilities within Pharmacovigilance include but are not limited to:
- Responsible for plans/instructions and SOPs for post approval surveillance within Sedana Medical.
- Review and approval of processed cases, AE/SAE reconciliation and safety coding as performed by the QPPV.
- Ensure that the handling of SAE in clinical trials and spontaneous reports (ADR) from the market, are collected, forwarded to the QPPV, assessed and entered into the safety database.
- Overview of safety activities in the department as well as those of the QPPV.
- Management of safety communication, if required and requested by the QPPV.
- Quality check of all literature cases and ICSR reports from the territory which are prepared by vendor before medical review step.
- Submit monthly reconciliation reports to the PV department.

MEDICAL INFORMATION
Primarily responsible for generating standard and customized medical information content to fulfill unsolicited Medical Information requests from both healthcare professionals (HCPs) and non-HCPs for Sedana Medical products.

Other tasks and responsibilities within Medical Information include but are not limited to:
- Improving of processes and deliverables within Medical Info.
- Monitoring of product trends.
- Training team members on Medical Info content and processes, mandatory rules and regulations.
- Reviewal and approval of any generated Medical Info material.
- Ensuring and supporting audit readiness for Medical Info at all times.
- Handling of complex inquiries escalated by field-based personnel.
- Regularly monitoring the quality and accuracy of Medical Info responses.


REGULATORY SUPPORT
Other tasks and responsibilities within Regulatory support may include but are not limited to:
- Supporting the development of efficient internal regulatory procedures and ways of working to support global product launch and commercialization.
- Supporting the development of efficient working practices with external partners.
- Managing relevant parts of the regulatory maintenance activities potentially including Life Cycle Management and geographic expansion.
- Supporting regulatory & quality inspections and internal audits.
- Supporting artwork development and maintenance in different geographic territories.


QUALIFICATIONS
The right candidate has a Bachelor’s degree or higher in Life Science, Pharmacy, Medicine or other relevant filed. You have minimum of 4 years of documented experience from the pharmaceutical industry including a minimum of 3 years from pharmacovigilance. Previous experience from working in a global regulatory environment is a plus. Strong computer skills and proficient in MS Office and a perfect command of English language, spoken and written, is an absolute requirement. If you speak Swedish it is advantage.

Further sought for experience includes:
- Experience in team and process set-ups of EU pharmacovigilance environment.
- Experience in internal audits and inspections.
- Knowledge of QPPV tasks like RMP, SDEA, SPC updates, PSMF etc.
- Knowledge and experience in Quality and compliance work.
- Experience in training, coaching, and mentoring other members of staff.
- Experience from work within Medical Information
- Experience from work within Regulatory Affairs

To succeed in this role you have a strong personal drive and a high sense of accountability. You have a "can-do attitude", enjoy solving problems, are meticulous and keen on data searches and have the ability to go fast from problems to actions. Furthermore, you are service minded, flexible a good communicator, team oriented, social and enjoy working in a global environment. To thrive at Sedana Medical you are entrepreneurial, pro-active and have the will to learn and grow on the job. To thrive at Sedana Medical you are entrepreneurial, pro-active and have the will to learn and grow on the job.


SEDANA MEDICAL
Sedana Medical develops and sells the medical device AnaConDa for the administration of volatile anaesthetics. The company has applied for marketing approval in Europe for a pharmaceutical candidate for inhaled sedation and expects an approval in the second half of 2021.

Our three company values, Explore, Collaborate and Trust, help shape our culture, and guides us in our daily work.

We have today direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. We are collaborating with external distributors in other parts of Europe, Australia, Canada, Asia, and South America. Sedana Medical was founded in 2005, listed on Nasdaq First North and is headquartered in Stockholm, Sweden.