What are the responsibilities and job description for the PHARMACOVIGILANCE PROJECT MANAGER position at Lifelancer?

About the job Pharmacovigilance Project Manager

Job Title : Pharmacovigilance Project Manager

Job Location : Cambridge, MA, USA

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level : Mid-Senior level

Job details

Posted

18 February 2025

Location

Cambridge, MA

Job type

Permanent

Reference

954319

Job Description Title : Pharmacovigilance Project Manager Location : Remote role, EST hours Duration : 06 Months (Possible Extension) Pay rate : $60 - $73 / Hr Top 3 Skills

PV CRO management
Audit and inspection readiness
PV process improvement

6-7 months assignment Experience

Minimum 4 years pharmaceutical or health care related industry experience

Required.

Minimum 3 years PV experience with 1 year experience working with CROs, vendors, and relationship management required

Global experience with CROs, vendors and relationship management preferred

Education

Bachelors required. Advanced degree in scientific / medical field preferred.

Good cross cultural understanding and experience

Experience in people management and well developed skills in teambuilding, motivating and developing people.

Demonstrated skills in negotiation and consensus decision making

Critical thinking and analytical skills and ability to make key decisions

Demonstrated effectiveness in external partner relationship management

Understanding of medical / scientific terminology

Good knowledge of PV regulations for the global pre-and post-market, i.e. FDA, EMA, ICH GVP

Experience with safety databases, including MedDRA and WHO Drug

Excellent written / oral communication skills

Accuracy and attention to detail

Flexible mindset

Team worker with collaborative approach

Ability to prioritize under pressure

Well developed organizational skills

Objectives

Serve as a primary liaison and point of contact for vendor operations and vendor oversight, including vendors performing case management, case intake (i.e., Call Centers), scientific literature review, etc.

Oversee operations performed by the PV BPO vendor including contract compliance, quality and timeliness of deliverables.

Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and / or vendors performing case management, case intake, literature review; call centers

Provide Subject Matter expertise (SME) during audits and inspections in the areas of case processing / case management activities, literature monitoring, legal case processing, vendor oversight, etc.

Accountabilities

Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according

to company timelines and quality standards

Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to global Health Authorities, alliance partners, local operating companies (LOCs) including SUSAR and SAE communication to ECs and investigators as applicable

In partnership with the Global Standards and Compliance team, direct and manage communication with alliance partners, LOCs and CROs regarding the evaluation and processing of ICSRs

In partnership with the Global Standards and Compliance team, lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements

Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level

Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https : / / dexian.com / to learn more.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

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Alternative WPA

Lifelancer ( https : / / lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https : / / lifelancer.com / jobs / view / 64a5f18c582f5eac638240a2d619c78c

Salary : $60 - $73

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