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★★★★★ Pharmacovigilance Director, Август Рисърч ООД
Месторабота София; Постоянна работа; Пълно работно време
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Pharmacovigilance Director

August Research is searching for a Pharmacovigilance Director to lead the formation of a PV Department within August Research’s Sofia office.

We are looking to hire experienced Pharmacovigilance Leader with 8 or more years of experience in Pharmaceutical leadership and/or Pharmacovigilance operations who is excited by the challenge of setting up a new PV operation to support safety reporting for ongoing clinical trials.

Job responsibilities will include:

• Build and maintain excellent relationships with colleagues and clients
• Build and maintain a Pharmacovigilance unit, maintaining high quality and compliance to timelines
• Ability to oversee Serious Adverse Event case processing, due diligence and compliance with quality and regulatory expectations
• Participate with proposals, pricing and attend client meetings
• Manage and resolve issues between clients and team
• Act as a Line Manager for a team of Safety Associates

Skills required:

• Prior supervisory experience demonstrating leadership expertise
• Knowledge of FDA and EMA regulations as they relate to Pharmacovigilance
• Proficient knowledge of medical/therapeutic areas and medical terminology
• Attention to detail in a highly regulated industry
• Ability to work independently and be a pro-active team player
• Excellent verbal and written communication skills
• Medical University graduates, MD preferred

Interested candidates should submit a CV and cover letter in English. Please be informed that only short listed candidates will be contacted.

The information provided by you in the selection process will be treated as personal and processed only for the evaluation of your eligibility for this selection. By submitting the above you agree the same to be processed by August Research, which is an administrator of personal data according to the Protection of Personal Data Act. The data will be deleted within 3-months after the closure of the selection process.

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