Pharmacovigilance Project Manager Job at Lifelancer, Cambridge, MA

cEdSaXEvUWFETm1jcEVtR2tGaHNaaDFV
  • Lifelancer
  • Cambridge, MA

Job Description

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 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.

Apply Now

"*" indicates required fields

This field is hidden when viewing the form

Applicant Tracking

Name*

First Last

Email*

Resume*

Accepted file types: pdf, docx, doc, txt, Max. file size: 50 MB.

Phone*

Current Zip Code

We are an equal opportunity employer. We honor diversity and are committed to creating an inclusive environment for everyone. Help us get to know you better by responding to these optional questions.

Race & Ethnicity

Hispanic or LatinoWhiteBlack or African AmericanAsianNative or Alaska NativeTwo or more racesI do not wish to disclose

Gender

MaleFemale

Disability

I Don't Have a Disability or Have a Record of Having a Disability.I Have a Disability or Have a Record of Having a Disability.I Do Not Wish to Answer

Protected Veteran

I am not a protected veteranI identify as one or more of the classificationsI choose not to self identify

By registering you agree to our Privacy Policy **

By registering you agree to our Privacy Policy *

Alternative

WPA

Lifelancer ( ) 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.

Job Tags

Permanent employment, Full time, Contract work, Local area, Remote job, Worldwide, Flexible hours,

Similar Jobs

LMT - Hartville

1st & 3rd Shift Powder Coating Technician Job at LMT - Hartville

 ...Job Responsibilities: Carry out production, inspection, packaging and Powder Coating machine operation duties Set up powder coating machinery and ensure all materials are readily available Effectively monitor production equipment Keep accurate inventory of... 

Resilience Enterprises

Brand Ambassador Job at Resilience Enterprises

 ...As a Brand Ambassador on your team, you would be responsible for providing exceptional customer service, driving sales, and ensuring a positive experience for customers. This role requires a combination of product knowledge, communication skills, and the ability to build... 

TalentWealth

Remote Certified Financial Planner Job at TalentWealth

 ...Financial and portfolio reporting Qualifications: Bachelors degree or higher Certified Financial Planner required FINRA series 7, 66 a plus Experience with goals-based planning software (ex.. eMoney, MoneGuidePro) Excellent interpersonal, communication... 

Akkodis

R&D Process Development Engineer Job at Akkodis

 ...About the Company - An R&D Process Development Engineer position in Bloomington, IN with an American manufacturer of medical devices is...  ...attributes for products, including evaluation based on technical and economic feasibility. Execute cost-effective systems in order to... 

EGS, Inc.

SmartPlant 3D Electrical Designer Job at EGS, Inc.

 ...Come join a growing multidisciplinary team of designers and engineers designing the next generation nuclear power plant. We are seeking a SmartPlant 3D Electrical Designer for immediate hire. The Designer must be eager to learn new skills to create feasible/practical solutions...