Full-Time Pharmacovigilance Physician II

• Review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
• Review includes coding, assessment of seriousness, listedness/expectedness and company causality, as well as writing of company comments, follow-up questions and analysis of similar events.
• Support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues.
• Review and provide input in periodic reports.
• Review literature screening search strategy and articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings.
• Support signal detection activities upon acquiring sufficient experience.
• Propose a course of action whenever a new risk is identified.
• Contribute to the preparation of PV procedures.
• Support the Project Manager, as well as the QPPV, on a day to day basis as needed.
• Medically qualified as a physician with +1 year of experience in pharmacovigilance (Or +1 year of experience in clinical medicine)

Skills:

• Excellent interpersonal skills.
• Ability to plan, organise, prioritise and execute multiple tasks.
• Ability to work effectively cross culturally and cross functionally and value the importance of teamwork.

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology.

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging Collaborative Partnerships

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