Safety Physician

Due to fast growth of our company we are currently recruiting a colleague for the position of SAFETY PHYSICIAN, who will:
- Review all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature).
- Conduct medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
- Ensure medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.
- Write safety section, including benefit risk assessment of all aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), DSUR/IND Annual reports and line listings of Suspected Unexpected Serious Adverse Reactions (SUSARs) for regulatory submission.
- Prepare and may present product safety issues at meetings, both internal and external.
- Author/review relevant sections of all aggregate safety reports and ensures the overall quality of documents.

Suitable candidate should have:
- Medical degree and a high level of medical competence
- Prior experience in Pharmacovigilance and medical writing (advantage)
- A thorough working knowledge of clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities
- Good organizational and prioritization skills, good interpersonal skills (i.e. team player)
- Working knowledge of MedDRA
- Flexibility and ability to adapt and learn quickly
- Ability to work under pressure and to tight deadlines
- Excellent communication and presentation skills in English (both written and spoken)

We offer:
- an opportunity to work in international team
- an attractive finance bonuses according to a good results
- flexible working hours with a possibility of home-office
- young and friendly team
- 25 days of holiday per year (instead of the standard 20 as per Czech law)
- pleasant offices in the center of Brno
- a possibility of professional courses and international conferences
- a possibility of part-time or full-time work
- 95 CZK Meal voucher (55% covered by the company)
- Company courses of English language and yoga lessons