Pharmacosmos is looking for a Drug Safety Operations Manager to join our Drug Safety department, and to work closely with the Director Drug Safety to manage spontaneous and clinical cases reported on Pharmacosmos human and veterinary products and tasks related to the Global Safety Database

About the team

The Drug Safety department is part of R&D at Pharmacosmos. We are a small group of six experienced and dedicated colleagues, managing global drug safety for our human and veterinary products. We are looking forward to welcoming you as an important part of the team in a progressive and innovative pharmaceutical company. You will work closely together with internal stakeholders such as R&D, Quality & Regulatory Affairs, Medical Affairs, Sales & Marketing, as well as with our affiliates and external collaboration partners across the world.

Key responsibilities of the Drug Safety Operations Manager

• Oversee and manage the day-to-day activities regarding cases from marketed human and veterinary products and clinical trials
• Manage individual cases spontaneously reported to Pharmacosmos and clinical trial cases for both human and veterinary products

This includes:

• Processing of Individual Case Safety Reports including Eudravigilance download, triage, data entry, coding, medical evaluation of non-serious cases, and follow-up,
• Perform global and local reconciliation of ADRs with Medical Information, Quality Complaints, Affiliates, and Commercial partners,
• Responsible for data retrieval for e.g. aggregate reports, signal detection, compliance, and authority requests,
• Monitor individual case safety report compliance and take the necessary corrective actions locally for late reporting,
• Perform World-Wide literature search,
• Author, update, and review of local PV procedures,
• Review pharmacovigilance agreements for inclusion of ADR exchange agreement language,
• Administrator of the Global Safety Database (Basecon) including MedDRA updates, assignment of users, maintain Company Drug Dictionary, and yearly system review,
• Project responsible for upcoming implementation of upgrades of the Safety Database to R3 in close cooperation with Basecon,
• Contribute to preparation of audits and inspections, be member of the team that interacts with auditors/inspectors and develop Corrective and Preventative Actions (CAPAs) in response to findings/observations in close cooperation with the QPPV Office

The position reports to Director Drug Safety

About you

As a professional, we expect you to:

• Have a relevant scientific degree, preferably as a health care professional such as nursing
• Have experience min. 3-5 years from the life science industry in a pharmacovigilance/drug safety/safety surveillance function or maybe from the regulatory authorities/drug agencies.
• Have good knowledge of PV systems and case processing
• Knowledge of the GVP modules
• Experience with drug safety databases and/or document management systems is an advantage

As a person we expect you to:

• Be pro-active, self-driven, well organized and with good oversight
• Have a positive energy, good interpersonal skills, and able to build sustainable business relations
• Have an eye for detail, accuracy, and quality
• Be a team-player as you will be part of a small team, but at the same time fully capable of assuming responsibility for your own tasks
• Work effectively and be flexible in a fast-paced environment with changing priorities
• Be an exact and precise communicator, fluent in English, both written and spoken

We offer

• An opportunity to join a small pharmacovigilance team with great humor, where you will take part in a wide variety of pharmacovigilance tasks
• Cross-functional and cross-cultural collaboration with colleagues and PV partners
• Opportunity to be part of Pharmacosmos’ inspiring working environment and continued global growth
• Flexible working environment supported by modern communication technology
• An exciting and challenging role where you can develop your personal and professional competencies

Additional information

Further information about the position can be obtained by contact Helle Heisel White on, +45 2788 8873. Your application and CV (in English) should be submitted to us as soon as possible and no later than 4th October 2020.

Please apply by clicking the Apply button at the top right. Note that Pharmacosmos, due to GDPR regulations, do not accept applications via e-mail.