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.

Responsibilities:

• 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.

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