Senior Manager, Pharmacovigilance Operations job in Waltham, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Pharmacovigilance

Location: United States

This vacancy has now expired. Please see similar roles below...

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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