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Lead Pv Scientist Jobs (NOW HIRING)

Replimune-2

Pharmacovigilance Scientist

Woburn, MA · On-site

$137K - $178K/yr

PV Scientist will collaborate closely with the safety physician and cross-functional partners to ... Lead post marketing case query preparation; closely work with PV compliance, PV operations and ...

Biogen

Sr Pharmacovigilance Scientist

Cambridge, MA · On-site

$141K - $188K/yr

As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical PV activities. Your responsibilities ...

Biogen

Sr Pharmacovigilance Scientist

Cambridge, MA

$141K - $188K/yr

As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical PV activities. Your responsibilities ...

ProPharma Group

The Senior PV Safety Scientist is also expected to lead by example and ensures quality standards are upheld within the company. Job responsibilities * Authoring and Quality review of Aggregate ...

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Lead Pv Scientist information

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How much do lead pv scientist jobs pay per year?

As of Sep 14, 2026, the average yearly pay for lead pv scientist in the United States is $112,722.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,500.00 and $123,000.00 per year, depending on experience, location, and employer.

What is a Lead PV Scientist?

Lead PV (Pharmacovigilance) Scientists are professionals responsible for overseeing the detection, assessment, understanding, and prevention of adverse effects or other drug-related problems. They lead teams in monitoring drug safety, manage safety data, and ensure compliance with regulatory requirements. Their role involves analyzing safety reports, preparing safety documentation, and communicating findings with regulatory authorities and internal stakeholders. Lead PV Scientists play a crucial part in safeguarding public health by ensuring that medicines are safe and effective throughout their lifecycle.

What are the key skills and qualifications needed to thrive as a Lead PV Scientist?

To thrive as a Lead PV Scientist, you need a robust background in pharmacovigilance, drug safety regulations, and life sciences, often supported by an advanced degree (PharmD, PhD, MD) and experience in safety data analysis. Proficiency with safety databases (such as Argus or ARISg), signal detection tools, and knowledge of global regulatory requirements is essential. Strong leadership, analytical thinking, and effective communication skills help manage teams and ensure accurate safety reporting. These competencies are vital to ensure the safe use of pharmaceutical products, regulatory compliance, and effective risk management.

What are some of the main challenges Lead PV Scientists face when overseeing pharmacovigilance activities across global teams?

Lead PV Scientists often coordinate pharmacovigilance (PV) operations across multiple regions, which can present challenges such as managing diverse regulatory requirements, ensuring timely and accurate adverse event reporting, and harmonizing processes among cross-functional teams. They must also foster strong collaboration between safety, clinical, and regulatory departments to maintain compliance and data integrity. Effective communication and project management skills are essential to navigate time zone differences and cultural nuances, ultimately ensuring patient safety and regulatory adherence worldwide.

What are popular job titles related to Lead Pv Scientist jobs?

For Lead Pv Scientist jobs, the most frequently searched job titles are:

Clinical - Pharmacovigilance (PV) Scientist

Madison, NJ

Omni Inclusive
See more jobs at Omni Inclusiveexternal

Full-time

Re-posted 25 days ago

Job description

Position is Onsite

Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary / Objective
Support Medical Safety Assessment Physicians (MSAP) in leading Safety Data Review (SDR) Teams. Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight. Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR). Ensure pharmacovigilance regulatory compliance with oversight, as needed.

Position Responsibilities

  • Lead Safety Data Review (SDR) Teams and participate in related PV and product-development subteam(s). Appropriately elevate signal detection findings impacting key MST activities, milestones, and documents to the MST Chair. Support individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs.
  • Author and contribute to specified PV sections of the PBRERs and DSURs with oversight, as needed
  • Author responses to safety data queries from health authorities including coordination and integration of scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to safety data/ad hoc queries and HA requests.
  • Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
  • Collaborate within and across Client functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required.
  • Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.

Experience Requirements:
Minimum of 3 to 5 years BS/RN; 1 to 3 years MS/PharmD/PhD/MD, or equivalent relevant Pharmaceutical Industry experience; Demonstrated ability to mentor and coach others.

Key Competency Requirements

  • Working understanding of medical concepts and some familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
  • Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
  • Ability to work well in cross-functional teams.
  • Good collaborative and communication skills with scientific subject matter.
  • Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions. Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
  • Understand aspects and methods for data analysis, interpretation and presentation.
  • Possess good working skills in MS Word, Excel and PowerPoint, including statistics

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