Director of Pharmacovigilance

Lawrence Harvey

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Job ID :

15373


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

North America,--California,San Francisco,


Key Skills :

Pharmacovigilance, Drug Safety, Director, Sr. Director


Salary :

Negotiable


Date Posted :

09 Oct, 2019



Company Name :

Lawrence Harvey


Location1 :

San Francisco




Job Category :

Drug Safety Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Director, Pharmacovigilance

Overview:

The Director will lead the ongoing signal detection monitoring, product risk-benefit assessment, and safety assessment activities of designated drugs and/or indications. The Director will work closely with the Medical Safety & Pharmacovigilance team and in addition will be a key member in one or more cross-functional clinical development and will report to Sr. VP of Drug Safety and Pharmacovigilance.

This position accepts considerable responsibility for the medical safety management of drugs in clinical development and in the post-marketing (preferred but not required) setting. The Director must possess strong analytical team player skills.

Responsibilities:

* Reviews all appropriate safety data from various sources throughout the product development lifecycle.
* Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, AESI etc.).
* Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised for a comprehensive medical review
* Participates in investigators' meetings to provide training on adverse events reporting as required.
* Authors/reviews relevant sections of all aggregate safety reports and ensures the overall quality of documents.
* Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product package labeling, Company Core Safety Information (CCSI)
* Responsible for responses to queries from regulatory authorities or health care professionals on safety issues and any legal queries and requests involving safety issues.
* Familiar with MedDRA, WHODRL and safety databases such as ARGUS.
* Ensure ongoing safety monitoring of investigational and marketed products to include detection of signal and assessment of risk, assessment of the risk-benefit balance of products and analysis of the overall safety of products.
* Assist in the creation, review and implementation of new SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety.
* Provides oversight over the monitoring of clinical trial safety and monitors site compliance with protocol-specified measures intended to ensure the safety of subjects.
* Contributes to regulatory filings (including NDAs/MAAs) and responses as needed
* Contribute to the creation and maintenance of Reference Safety Information, and the safety sections of Investigator Brochures for all investigational products
* Participate in in inspection readiness activities and preparation as needed
* Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)

Qualifications:

* Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)
* Minimum 5-8 years for experience in pharmaceutical safety, preferred work experience in metabolic and hepatic disease
* Strong skills in the management of safety information originating from both clinical development and post-marketing sources
* Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
* Demonstrated competence in obtaining, analyzing, disseminating and reporting safety information in compliance with global regulations.
* Demonstrated experience in managing business processes outsourcing vendors and relationships
* Strong team player in a multifunctional, multicultural, growing organization.
* Ability to operate objectively and independently as a leader and as a member of a team, as required.
* Ability to interpret and apply applicable regulations to resolve issues and ability to develop business solutions to complex problems.
* Strong organizational, project management, technical and problem-solving skills.
* Well-developed presentation, communication and interpersonal skills, including strong oral and written communication skills.
* Experience and extensive working knowledge of MedDRA, Clinical Database (eg: RAVE), safety databases (i.e.: ARISg, ARGUS), Microsoft Office suite (Word, Excel, PowerPoint)


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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