Proclinical is currently recruiting for a Pharmacovigilance Scientist for a biotechnology company located in Cambridge, MA. Successful candidate will contribute to the day-to-day operational activities of the function of PV-SQI and ensures that performed tasks comply with DS and PV SOPs and policies, best industry standards and applicable regulations.
- Provide analysis including literature search and analysis.
- Conduct signal detection and risk management planning activities to support Global Safety Officer.
- Project lead and authoring of periodic safety reports.
- Lead responses to regulatory queries in conjunction with Safety Physician.
- Monitor compliance with regulations, PV agreements and internal SOPs.
- Review and monitor compliance through various monitoring reports and other oversight activities. Ensure the implementation of effective corrective and preventative action plans.
- Participate in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
- Work with QA department to maintain a state of high PV inspection readiness across all regions/countries.
- Performance management of PV systems.
- Participate in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections; prepare responses to audit findings that concern the DS and PV department.
- Represent Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
- Provide safety operations support in daily case processing, tracking of (S)AE queries and SUSAR cases.
- Participate and project management of Safety Data Management for established SDEAs.
Skills and Requirements:
- Bachelor's degree in nursing, pharmacy, or other health care related profession or life sciences required.
- Master's or Doctorate level degree in health care related profession preferred, but not essential.
- 3+ years of experience in drug safety/pharmacovigilance in a pharmaceutical industry setting or the equivalent.
- Global pharmacovigilance operations experience with products in development and/or post market.
- Safety database, MedDRA coding and data entry experience.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Strong analytical and problem-solving skills with superb attention to detail.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to work within a cross-functional, matrixed team.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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