Lachman Consultants is in need of Per Diem Consultants with an expertise in Pharmacovigilance and Drug Safety for Pharmaceutical, Biotechnology, and Medical Device products, from preclinical studies to post-market product. Must have demonstrable hands-on experience and skills in the following areas:
- Global pharmacovigilance and drug safety auditing, compliance, and remediation
- Global processes and systems for pharmacovigilance and drug safety
- Quality systems and processes related to Pharmacovigilance
- Expertise in applicable US and EU laws, regulations, guidances, and best practices
- Clinical trial and post-marketing case processing and reporting; gap analysis, audits and mock inspections;
- Safety data exchange, quality agreements and quality management plans
- Electronic data capture and data mining
- Safety signal detection and analysis; safety review programs
- Pharmacovigilance training and education
Consultants must have a minimum of a Bachelor’s degree in life sciences or related field and 10 years’ related experience, as well as detailed knowledge of current FDA regulations and expectations. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly.
If you meet all of the qualifications please submit your full chronological resume via the Lachman website or to firstname.lastname@example.org. No phone calls please. Thank you.