In this role you’ll have the opportunity to be a true leader, using your ability to influence and impact the direction of the entire organization
You’ll work alongside a very accomplished senior team and you’ll have the opportunity to drive the development of departmental policies and procedures. Reporting to the Chief Medical Officer, as a visionary leader you’ll lead the drug safety and pharmacovigilance operations team toward a world class medical safety organization.
This is a rare opportunity to be an influential contributor to a passionately driven group that is initiating their registrational development plans. At Mersana, patient safety is of the highest priority. We see a talented individual to drive the pharmacovigilance and drug safety function and add to the strategic leadership of the organization. Your primary responsibility will be to provide medical/scientific and operational expertise necessary to establish and maintain an industry-leading global pharmacovigilance capability in support of the company’s early to late-stage assets.
Additionally, you’ll develop the PV strategy, operating model, execute on the strategy and proactively identify emerging potential and/or urgent safety issues, to ensure the management of any identified safety risks effectively, and to communicate accordingly. You will also monitor and manage the ongoing safety profile of products to maximize the understanding of risks through proactive review of all relevant pre‐and post‐marketing safety data, medical analysis and decision making. Your contributions will include the ability to influence critical decision making across the portfolio of programs
Mersana’s Strategic Objectives:
At Mersana, we are driven by the strength, tenacity, and courage of those battling cancer – we are single-minded in our resolve to deliver new therapies that not only keep cancer at bay but improve the lives of patients diagnosed with cancer. We are dedicated to improving how physicians care for their patients, and how caregivers cope with looking after a loved one or friend.
Strategic Leadership Objectives will include:
- Playing a critical role in shaping the Pharmacovigilance process to address cancers with a commitment to putting patients first.
- Helping advance assets from early to late stages of development, through major regulatory submissions and commercialization.
- Working closely with the Chief Medical Officer, other members of Senior Management and Function Heads in the creation and execution of risk management plans across multiple programs
- Being a key contributor to the continuous development of a corporate environment that is thoughtful about strategy and tactics, culturally intellectual and energetic.
Your Personal Growth Opportunity:
- Senior management is committed to establishing a robust medical group allowing this leader to build effective teams. The executive team is invested in this hire and willing to sculpt this role to ensure experience is gained in areas of interest.
- As the company continues to grow, this will allow for new strategic leadership opportunities
How do you know if you’re the right fit?
You’ll have the following experience:
- In the creation and oversight of the Pharmacovigilance department, including hiring of staff. Building and managing a team of medical professionals (at various levels of expertise) to implement the hematology/oncology strategy in a collaborative environment
- Being accountable for providing medical and scientific expertise regarding the safety and risk assessment of the product portfolio at all stages of the product lifecycle and for the establishment of the strategic plans and policies. Recognizing and escalating significant issues relating to compliance, budgets, timelines, or other issues that jeopardize business objectives
- Defining and implementing methods for the collection, evaluation, management, and communication of safety data from all sources regarding products in development.
- Advising clinical development teams on safety data reporting, collection, surveillance activities and documentation while being in command of our safety profile.
- Ensuring applicable review and oversight of Pharmacovigilance systems in all aspects, including database, SOPs, compliance, audits, etc.
- Contributing to regulatory responses, Investigator’s Brochure (IBs); provides standardized safety language where required for informed consent forms (ICFs), study protocols, and other documents as required.
- As a content owner /author of relevant sections of investigational and marketed product pharmacovigilance related documents (e.g. DSUR, PBRER).
- Providing medical/clinical review of applicable Individual Case Safety reports (ICSRs).
- Ensuring compliance with health authority regulations in all aspects of PV case processing and reporting; tracks compliance of expedited safety reports in relation with Pharmacovigilance vendors.
- Managing the aggregation of data for safety signal detection, for its analysis and their appropriate reporting, including Developmental Safety Update Report (DSUR) and other periodic safety line listings as required. Performs signal detection activities and provides written reports to Senior Management. Develops and implements risk management plans in accordance with regulatory requirements. Collaborating with Pre-clinical and with Clinical to better assess and understand safety profiles and to prepare safety surveillance activities. Author aggregate reports and benefit/risk assessments
- Managing and reviewing reconciliation SAE data between clinical and safety databases.
- Assisting with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closed.
- Reviewing submissions to ensure procedural compliance and to assess the medical safety content for accuracy.
- Providing strategic or operational input on project teams and interacts with senior management to report project updates.
- Remaining informed of all appropriate current health authority regulations and guidance globally.
- Initiating and maintaining Safety Data Exchange Agreements with business partners.
- Leading the establishment and implementation of best practices to create efficiencies for the function
- Designing, implementing, and managing Risk Evaluation and Mitigation Strategies ensuring that benefits outweigh possible risks.
- Being responsible for ensuring inspection readiness for FDA or other HA inspection activities related to PV
- Leading the medical evaluation/review of safety data and ensure the oversight of safety signal detection activities and review for the allocated portfolio of products in development and on the market.
- In line with corporate objectives, providing relevant medical counsel and scientific guidance to all teams
The other stuff
- This is typically a role best suited for Medical Degree (MD or equivalent) candidates who possess extensive experience in pharmaceutical/ biotech with risk management and Pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.) experience with an expertise in Oncology and 10+ years' experience in global clinical safety in drug development and pharmacovigilance.
Additional qualifications include:
- Proven track record in creating and sustaining a leading‐edge, high quality Pharmacovigilance function within the complex global regulatory-pharmacovigilance environment.
- Thorough understanding of ICH Good Pharmacovigilance Practices and Good Clinical Practices, including broad application of knowledge in different therapeutic areas and biologics.
- Full knowledge of US and EEA compliance regulations and guidance on medical information practices; experience developing medical information SOPs. Both pre-market and post-market experience preferred.
- Ability to comprehend and synthesize complex data and experience in the identification, analysis and implementation of programs and procedures required to achieve corporate objectives.
- Proven track record of successful management of product safety matters (product recall, regulatory inspection, etc.)
- Demonstrated experience in the preparation of global risk management plans, aggregate reports, and Company core safety information
- Experience with CROs, vendors, and relationship management preferred.