Job Description

Job Overview

We are seeking an experienced, talented, and motivated healthcare professional to fill the role of Senior Manager/Associate Director of Pharmacovigilance based in our East Windsor, NJ office. This position will provide strategic leadership and tactical oversight of all pharmacovigilance (PV) and risk management activities, ensuring compliance with US and global regulatory requirements.

The Head of Pharmacovigilance will be responsible for leading the PV function, ensuring patient safety is integrated into all aspects of the drug development and commercialization processes. The position will be responsible for building a strong team of internal and external employees to as required to ensure compliance with regulations. Key responsibilities include overseeing product safety, leading risk management strategies, directing safety data management, interacting with health authorities, collaborating cross-functionally, improving processes, conducting training, and managing the PV team.

This role will report into the President and be an integral part of the ensuring Acrotech is being built on strong systems and processes. The role will be a part of the senior leadership team and would require interaction with senior members of the parent company marketing partners and FDA/Other health authorities.

The Senior Manager/Associate Director of Pharmacovigilance will work closely with senior management to ensure the PV system is designed and managed to be up to date with existing guidelines. The position will have to be abreast of anticipated changes nationally and internationally and gear the organization and partners to be prepared. This will require ability to keep the organization compliant alongside fiscal prudence.

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.

Qualifications - Skills & Requirements

• Education: A health care professional degree is required (e.g., MD, PharmD, RN, PA, NP), with an MD or PharmD often preferred.
• Experience: 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.
• Expert Knowledge: 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.
• Technical Proficiency: 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. Transition experience from one database vendor to another is preferred. Having conducted audits of vendors and marketing partners is preferable.
• Core Competencies: 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).
• Travel: Willing & able to travel domestically and internationally, as required (up to 30%).

Education & Experience

• Education: A health care professional degree is required (e.g., MD, PharmD, RN, PA, NP), with an MD or PharmD often preferred.
• Experience: 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.
• Expert Knowledge: 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.
• Technical Proficiency: 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. Transition experience from one database vendor to another is preferred. Having conducted audits of vendors and marketing partners is preferable.
• Core Competencies: 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).
• Travel: Willing & able to travel domestically and internationally, as required (up to 30%).

Compensation: $145,000 to $165,000, Annual Bonus, Long-term Incentive Plan

• 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

Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements

No Additional Requirements

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

Job Tags

Full time, Temporary work, Work at office, Flexible hours,

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