Senior Manager, Pharmacovigilance Operations

Deciphera Pharmaceuticals - Waltham, MA

Full-time - Senior

Waltham, MA

Chemical Manufacturing

About the position

The Senior Manager, Pharmacovigilance Operations plays a crucial leadership role in guiding the Pharmacovigilance department at Deciphera Pharmaceuticals. This position is responsible for overseeing adverse event case management, supporting study teams, maintaining drug safety databases, and collaborating on risk management and pharmacovigilance for clinical trials and post-marketing activities. The role requires ensuring compliance and efficiency in pharmacovigilance activities, vendor oversight, and training, while also contributing to safety monitoring and regulatory compliance.

Responsibilities

• Perform critical safety vendor oversight to ensure efficient, consistent, and compliant pharmacovigilance activities.
• Coordinate day-to-day operational ICSR activities in collaboration with vendor management personnel.
• Review incoming adverse events to determine required actions.
• Oversee vendor case processing and submission activities, monitoring compliance through various reports.
• Manage vendor oversight, tracking KPIs, metrics, and quality control of SAE/ICSR cases in the safety database.
• Facilitate training on GVP Modules and relevant safety-related guidance documents for vendor personnel.
• Lead PV Operations to ensure consistent and compliant processing of safety reports from clinical trials.
• Maintain an externally hosted electronic safety database for tracking serious adverse events.
• Provide technical/data management support for accurate information entry and retrieval from the safety database.
• Perform safety monitoring and signal detection activities, including signal identification and evaluation.
• Support oversight and management of global safety data exchange agreements and contracts.
• Develop and maintain Medical Safety and Pharmacovigilance documents, including Safety Management Plans and SOPs.
• Lead preparation of safety-related plans with partners and CROs.
• Provide guidance to project teams on safety-related areas, including protocol development.
• Collaborate with Regulatory Affairs and Quality Assurance to implement regulatory safety reporting guidelines.
• Contribute to safety sections of clinical study reports and regulatory filing documents.
• Assist with safety-related queries from regulatory authorities or Ethics Committees.
• Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities.
• Support the development of Deciphera's PV infrastructure and safety systems.
• Oversee deviation and CAPA activities related to safety reporting processes.
• Adhere to company policies and regulations regarding adverse event reporting.

Requirements

• Bachelor's or advanced degree in life science, nursing, pharmacy, or related healthcare profession.
• 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry.
• Experience with Argus Safety database is essential.
• Solid understanding of US and ex-US pharmacovigilance regulatory requirements.
• ICSR submission experience is highly preferred.
• Knowledge of MedDRA and WHO Drug dictionaries.
• Experience in overseeing and managing vendors.
• Experience in pre- and post-approval pharmacovigilance activities, including safety reporting.
• Strong clinical knowledge and analytical ability to evaluate clinical and safety data.
• Proficient verbal and written communication skills with attention to detail.
• Ability to manage work priorities and build collaborative relationships.
• Demonstrated problem-solving skills and a strong sense of urgency.
• Proficient in standard computer software (Word, Excel, PowerPoint).
• Previous experience with safety database programs, including configuration and validation.

Benefits

• Non-accrual paid time off
• Summer vacation bonus
• Global company-wide summer and winter shutdowns
• Annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for health care and/or dependent care
• Family planning benefit
• Generous parental leave
• Car allowance (if applicable)