Medical Safety Director
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Holbæk
Would you like to use your competencies to contribute to drug safety in an innovative pharma company?
You will be a part of Global Drug Safety which consists of 4 teams: Operations, QPPV office, PV Technology and Partnering, and Medical Safety. The team has doubled its size since 2019 and will continue to grow. Currently, the Global Drug safety organisation consists of 11 employees and this role will report directly to the Head of Global Drug Safety and work very closely with the other Medical Safety Director in the team. The team culture is characterised by fast pace, quality, respect, sharing, flexibility, humour, and social engagement.
Our team is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
The Medical Safety Director position is a specialist role with the responsibility for safety aspects of both clinical trial development and post marketing activities. The role offers the right candidate great learning opportunities as the candidate will need to take on a broad role and a variation of tasks on both strategic and operational level. The candidate will collaborate closely across the organization in making the right strategic decisions on the safety agenda and in the preparation of important PV documents. This role gives the right candidate a unique opportunity to have influence on vital safety decisions in Pharmacosmos. With the position based at the HQ the candidate will be close to key stakeholders of the whole value chain gathered at the same site.
Clinical tasks:
Post Marketing tasks:
Other tasks:
You have a relevant background as Medical Doctor or equivalent.
It is key to us, that you have a strong quality mindset, and work in a structured and organized manner. You work independently with a self-driven learner mindset, with a key interest to share your knowledge with the team.
As a person, we expect you to be:
As a professional, we expect you to contribute with:
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than August 24, 2023.
About the team
You will be a part of Global Drug Safety which consists of 4 teams: Operations, QPPV office, PV Technology and Partnering, and Medical Safety. The team has doubled its size since 2019 and will continue to grow. Currently, the Global Drug safety organisation consists of 11 employees and this role will report directly to the Head of Global Drug Safety and work very closely with the other Medical Safety Director in the team. The team culture is characterised by fast pace, quality, respect, sharing, flexibility, humour, and social engagement.
Our team is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
About the job
The Medical Safety Director position is a specialist role with the responsibility for safety aspects of both clinical trial development and post marketing activities. The role offers the right candidate great learning opportunities as the candidate will need to take on a broad role and a variation of tasks on both strategic and operational level. The candidate will collaborate closely across the organization in making the right strategic decisions on the safety agenda and in the preparation of important PV documents. This role gives the right candidate a unique opportunity to have influence on vital safety decisions in Pharmacosmos. With the position based at the HQ the candidate will be close to key stakeholders of the whole value chain gathered at the same site.
KEY RESPONSIBILITIES
Clinical tasks:
- Responsible for safety aspects of clinical development in Pharmacosmos
- Acting Global Medical Safety Monitor in ongoing clinical trials
- Safety responsible for protocol planning/writing, Statistical Analysis Plan, Investigators Brochure, Development Safety Update Report, Final Study Report, Safety Management Plan, electronic Case Report Form
- Taking part in Data Monitoring Committees
- Case handling / medical evaluation of clinical cases
- Preparation of Clinical Overview and Summary
- Be part of cross functional Clinical Trial Teams
Post Marketing tasks:
- Preparation of aggregated reports
- Development of Risk Management Plans
- Medical evaluation of ICSRs
- Signal detection
Other tasks:
- Take part in inspections and audits as subject matter expert
- Take part in safety review meetings both in relation to post marketing and clinical development
- Prepare responses to requests from authorities
- Safety evaluation in relation to potential quality issues
- SOP writing and maintenance within areas of responsibility
ABOUT YOU
You have a relevant background as Medical Doctor or equivalent.
It is key to us, that you have a strong quality mindset, and work in a structured and organized manner. You work independently with a self-driven learner mindset, with a key interest to share your knowledge with the team.
As a person, we expect you to be:
- Pragmatic, problem solver, and curious
- Team player, focused on the overall success of the team, the project, and Pharmacosmos
- Strong communicator and good at building professional relations to colleagues, collaborators, and business partners
- Proactive and able to prioritize work in a changing environment
- You are determined to do and be your best and take pride in enabling the best work of others on the team
As a professional, we expect you to contribute with:
- relevant education as Cand.med or equivalent
- 5+ years’ experience in drug safety/pharmacovigilance covering both clinical development and post-marketing
- Solid clinical judgement: experience in nephrology, cardiology, hematology is a plus
- Experience with PV audits/ Inspections and worldwide regulatory authorities’ interactions
WE OFFER
- An opportunity to join a dedicated team with great humour, and an open and friendly atmosphere
- Cross-functional and cross-cultural collaboration with colleagues and partners
- An independent function in global settings, with a wide variety of pharmacovigilance tasks and responsibilities
- Inspiring and flexible working environment.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
Additional information
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than August 24, 2023.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 15.8.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Holbæk
- Torsdag den 24. august 2023
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