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Job Title: Senior Manager, Pharmacovigilance Operations 

Department: Patient Safety & PV

Location: Remote US

Job Title: Senior Manager, Pharmacovigilance Operations

Location: Remote US

Reports To: Senior Director, Pharmacovigilance Operations

Overview of Role:

Senior Manager, Pharmacovigilance (PV) Operations will report directly to the Senior Director, Pharmacovigilance Operations. The Senior Manager PV Operations will support the PV team through PV vendor management, oversight of case processing/submissions, aggregate report submissions, and partner management (if applicable). This role encompasses monitoring of PV Compliance and key performance indicators (KPIs) / key quality indicators (KQIs) through activities including, but not limited to:

  • Development of PV documentation (SOPs, WIs, SAE/pregnancy forms, ICFs)

  • Development of SMP (safety management plan)

  • Protocol deviation, CAPA, and PV Training management

  • Support Safety Science on signal detection, risk management, and literature search activities

  • Communication with internal and external shareholders

  • Support audits and inspections

?Role and Responsibilities:

Oversight of PV:

  • Support of inspection readiness preparation and maintenance relating to PV activities;

  • Support onboarding and training of new employees, and creation and maintenance of a PV Training Matrix for internal and external stakeholders;

  • Routine monitoring of compliance including creation and monitoring of KPIs and KQIs to assess PV quality from CROs, vendors, external partners, and internal stakeholders; oversight of case processing activities and submission of SUSARs; submission of aggregate reports (e.g. DSUR, PSUR, PADER, 6MLL/3MLL); development and implementation of a master SMP; and oversight of external shareholders, license partners and vendors through development, implementation, and compliance of Pharmacovigilance Agreements (PVAs) and/or Safety Data Exchange Agreements (SDEAs).

Process development:

  • Actively support the development of PV Standard Operating Procedures (SOPs), and Working Instructions (WIs);

  • Support the review of cross-departmental documents where PV holds responsibility for a step in the process;

  • Support in the creation of PV CAPA process to identify, assess, address, and monitor non-compliance, including ensuring proposed corrective actions plans are executed and review process is in place for identifying trends;

  • Support the development of Regulatory Intelligence for regulatory requirements of Safety Reports by different Regulatory Authorities.

Stakeholder collaboration:

  • Support Safety Science with signal management and literature search activities with internal and external stakeholders;

  • Support cross-functional teams in overall Safety Management and risk minimization measures in support of clinical development, regulatory filings, and safety reporting requirements;

  • Work with Quality Team to plan, execute and report audits of vendors, partners and CROs;

  • Work with Quality Team to support external audits and inspections.

Experience, Education and Specialized Knowledge and Skills:

  • Bachelor’s degree in a health related field (RN, MSN, MPH, etc.) and a minimum of 5/8 years of experience in PV in Biotech, Pharma or a CRO.

  • Prior experience working within a Safety Database (Argus, ARISg, etc.).

  • Prior experience in Clinical Safety and Risk Management with an understanding of the various stages of the product life cycle both

  • Experience working in a matrixed and fast-paced environment and able to manage multiple projects with an ability to creatively resolve issues and mitigate risks.

  • Ability to translate PV knowledge and expertise into action.

  • Demonstrated ability to monitor multiple projects, and actively track timelines.

  • Knowledge of ICH guidelines relevant to PV and of global PV regulations such as FDA, EMA, MHRA, Health Canada, etc.

  • Experience working with management and cross-functional stakeholders (e.g., Clinical, Regulatory, Quality), including an ability to influence without authority.

  • Effective collaboration and interpersonal skills. Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable

  • Strong computer and database skills

  • Attention to detail, accuracy and confidentiality

  • Clear and concise oral and written communication skills

  • Excellent organizational skills

  • Critical thinking, problem solving, ability to work independently.

  • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.

  • Communicate effectively and articulate complex ideas in an easily understandable way

  • Prioritize conflicting demands.

  • Work in a fast-paced, demanding and collaborative environment

The pay range for this role is $165,000-$180,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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