Acrotech Biopharma Inc · 2 days ago
Senior Manager/Associate Director Pharmacovigilance
East Windsor, NJ
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$145K/yr - $165K/yr
10+ years expAcrotech Biopharma Inc is seeking an experienced healthcare professional for the role of Senior Manager/Associate Director of Pharmacovigilance based in East Windsor, NJ. This position will provide strategic leadership and oversight of pharmacovigilance and risk management activities, ensuring compliance with regulatory requirements while fostering a culture of safety and accountability.
BiotechnologyMedicalPharmaceutical
Responsibilities
Strategic Oversight & Compliance: Oversee all aspects of product safety across clinical development and post-marketing surveillance, ensuring full compliance with relevant global regulations and internal SOPs, including FDA, EMA, and ICH guidelines
Risk Management: as required lead the evaluation, development and implementation of Risk Evaluation and Mitigation Strategies (REMS) in the US
Safety Data Management: Direct and monitor the entire process of collecting, evaluating, and reporting safety data for all company products, including individual case safety reports (ICSRs) and aggregate safety reports (PADERs, DSURs, PBRERs, etc.). Assessment of existing database and evaluation of alternate systems as required
Health Authority Interactions: Serve as the primary point of contact for safety-related issues and represent the PV function during health authority interactions, internal and external audits, and inspections
Cross-functional Collaboration: Serve as a liaison between the PV team and cross-functional stakeholders, including Clinical Development, Regulatory Affairs, Medical Affairs, Finance and external vendors, to harmonize safety practices and ensure safety considerations are integrated into overall company strategy
Process Improvement & Training: Drive continuous improvement initiatives to advance PV operational excellence including updating of SOPs and oversee the development and delivery of PV awareness training for all employees and vendors. This includes overall responsibility for Quality Management System
Leadership & Management: Provide leadership and guidance to the PV team and junior staff, fostering a culture of accountability and continuous development
Manage Audits: Risk assessment of vendors and marketing partners and conducting audits in planned manner. Provide improvement suggestions and closure of audits in a timely manner
Fiscal Responsibility: Prepare and manage in a financially prudent manner the budgets to optimally run the department including internal personnel and external vendors
Qualification
Required
A health care professional degree is required (e.g., MD, PharmD, RN, PA, NP), with an MD or PharmD often preferred
A minimum of 10+ years of relevant experience in pharmacovigilance and drug safety within the pharmaceutical/biotechnology industry, covering both clinical trial and post-marketing environments, with proven safety leadership experience
In-depth knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH), signal detection, risk management, and benefit-risk assessment. Direct experience in FDA/Health authority audits is a must
Strong technical aptitude with safety databases (e.g., Oracle ARGUS Safety Database) and MedDRA coding is required
Experience in Quality Management System implementation and maintenance including change management, CAPA & Deviation Management
Excellent written and oral communication skills, strong analytical and problem-solving skills, strategic thinking, prudent decision making, proactive behavior, and the ability to collaborate effectively across multidisciplinary teams are essential
High level computer skills required (e.g. MS Word, Excel, PowerPoint)
Willing & able to travel domestically and internationally, as required (up to 30%)
Preferred
An MD or PharmD is often preferred
Transition experience from one database vendor to another is preferred
Having conducted audits of vendors and marketing partners is preferable
Benefits
Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
Dental Benefits with three dental plan options through CIGNA
Vision Plan with two plan options through VSP
Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
Disability Insurance, Voluntary Short-Term Disability and State Disability
Long-Term Disability (LTD), State (short term) disability - where applicable
FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available
HSA (Health Savings Account)
401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
Critical Illness and Accidental Insurance
Legal and Identity Theft Insurance
Paid Time Off - Paid vacation, PTO, Holiday
Company
Acrotech Biopharma Inc
Founded in 2018, Acrotech Biopharma Inc was formed as a global platform to commercialize innovative proprietary medications.
51-200 employees
H1B Sponsorship
Acrotech Biopharma Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Growth StageRecent News
Google Patent
2025-02-16
Company data provided by crunchbase