Senior Manager, Pharmacovigilance Operations
Proclinical are recruiting for a Senior Manager, Pharmacovigilance Operations to join a biotech organisation. This role is on a permanent basis and is located in the United States.
- Accountable for enabling training, which involves training GVP modules ad pertinent US & EMA safety-linked guidance documents and processes.
- Monitor maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from the company's clinical trials.
- Guarantee that international clinical trials case reporting procedure is effective and compliance with reporting needs detailed within the safety management plans/PV agreements.
- Guide the preparation of safety-linked plans with partners and CROs.
- Offer leadership and assistance to project teams for safety-linked areas, which involves protocol development and study performance.
- Partake in the preparation of pertinent safety sections of clinical study reports, annual reports, expedited safety reports and any other regulatory archiving documents.
- Support the response to safety-connected questions from regulatory authorities or ethics committees if required.
- Cooperate with others to guarantee alignment among case management, aggregate reporting, and signal actions.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a life science, nursing, pharmacy or any other healthcare linked discipline.
- Demonstrable experience in pharmacovigilance within a pharmaceutical organisation.
- Familiarity with Argus Safety database.
- Comprehension and expertise on US and ex-US pharmacovigilance regulatory needs such as US code of federal guidelines; European union GVP legislation; and ICH regulations.
- Acquaintance with ICSR proposals would be ideal.
- Expertise on MedDRA and WHO Drug dictionaries.
- Prior involvement with monitoring and handling vendors.
- Familiarity with pre- and post-approval pharmacovigilance actions, which involves safety reporting.
- Clinical know-how and analytical skills to evaluate, review, comprehend and synthesise clinical and safety data.
- Communication skills both verbally and in writing.
- A high attention to detail with the ability to meet deadlines.
- Works well independently with the capacity to handle prioritise.
- Works well in a team with the ability to work on various projects concurrently.
- Able to resolve issues.
- Capable of working well under pressure.
- Computer literacy.
If you are having difficulty in applying or if you have any questions, please contact Callum Mitchell at +44 203 398 6613.
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.