Senior Manager, Pharmacovigilance Operations Lead
3 weeks ago
Deciphera Pharmaceuticals is seeking a highly skilled Senior Manager, Pharmacovigilance Operations to join our team. As a key member of our Pharmacovigilance department, you will be responsible for providing direction and oversight to ensure the efficient and compliant management of adverse event case management, study team support, and risk management for all Deciphera Pharmaceuticals Clinical Trials and post-marketing activities.
Key Responsibilities:- Perform critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent, and compliant manner.
- Coordinate day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s), review incoming adverse events to determine action required.
- Provide oversight and review of vendor case processing and submission activities by external vendor, including the review and monitoring of compliance through various monitoring reports and other oversight activities.
- Manage Vendor Oversight, including tracking of KPIs, metrics, and QC of SAE/ICSR cases in Safety database.
- Facilitate training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures.
- Develop and maintain Medical Safety and Pharmacovigilance related documents, including Safety Management Plans, SOPs, and Work Instructions.
- Lead preparation of safety-related plans with partners and CROs.
- Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct.
- Work cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into Deciphera practices and procedures.
- Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports, and other regulatory filing documents.
- Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS, etc.
- Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed.
- Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities.
- Assist with the ongoing review of TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports in support of regulatory submission activities, signal detection, and management activities, or in response to ad hoc safety inquiries from health authorities.
- Support the development of Deciphera Pharmaceutical PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective.
- Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs.
- Adhere to company policies and applicable regulations, including reporting of adverse events to regulatory agencies.
- Bachelor's/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare-related profession (MD, RN, PharmD, NP, PhD, MPH, etc.).
- 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry.
- Experience with Argus Safety database is a must.
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines).
- ICSR submission experience is highly preferred.
- Knowledge of MedDRA and WHO Drug dictionaries.
- Experience with overseeing and managing vendors.
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting.
- Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data.
- Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines.
- Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels, and remain flexible to the needs of the teams/projects.
- Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Proficient in standard computer software (Word, Excel, and PowerPoint presentations).
- Previous experience and formal training with safety database programs, including configuration and validation activities.
Deciphera offers a comprehensive benefits package that includes, but is not limited to:
- Non-accrual paid time off.
- Summer vacation bonus.
- Global, company-wide summer and winter shutdowns.
- An 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 either health care and/or dependent care.
- Family planning benefit.
- Generous parental leave.
- [If applicable] Car allowance.
Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas, and our European operations are run out of Switzerland.
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
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